FDA 510(k) Applications for Medical Device Product Code "NBW"
(System, Test, Blood Glucose, Over The Counter)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K130094 | ABBOTT DIABETES CARE | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | 06/27/2013 |
| K142928 | ABBOTT DIABETES CARE INC | FreeStyle Precision Neo Blood Glucose Monitoring System | 09/30/2015 |
| K062770 | ABBOTT DIABETES CARE INC. | COPILOT HEALTH MANAGEMENT SYSTEM | 12/14/2006 |
| K051839 | ABBOTT DIABETES CARE INC. | FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 | 03/09/2006 |
| K050500 | ABBOTT DIABETES CARE INC. | FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM | 06/27/2005 |
| K031260 | ABBOTT DIABETES CARE INC. | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 | 12/19/2003 |
| K092638 | ABBOTT DIABETES CARE INC. | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 | 06/15/2010 |
| K051802 | ABBOTT DIABETES CARE INC. | FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM | 08/09/2005 |
| K120568 | ABBOTT DIABETES CARE INC. | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM | 03/29/2012 |
| K070850 | ABBOTT DIABETES CARE INC. | FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM | 04/10/2007 |
| K092602 | ABBOTT DIABETES CARE INC. | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System | 05/14/2010 |
| K171941 | Abbott Diabetes Care Inc. | FreeStyle Precision Neo Blood Glucose Test Strips | 09/27/2017 |
| K140371 | ABBOTT DIABETES CARE INC. | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) | 09/30/2014 |
| K153330 | Abbott Diabetes Care Inc. | FreeStyle Precision Neo H Blood Glucose Monitoring System | 02/19/2016 |
| K132511 | ABBOTT DIABETES CARE INC. | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | 12/24/2013 |
| K020866 | ABBOTT DIABETES CARE INC. | FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM | 06/11/2002 |
| K012014 | ABBOTT DIABETES CARE INC. | MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM | 12/05/2001 |
| K080960 | ABBOTT DIABETES CARE INC. | PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS | 09/05/2008 |
| K081975 | ABBOTT DIABETES CARE INC. | RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) | 11/26/2008 |
| K123089 | ABBOTT LABORATORIES | FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 | 04/05/2013 |
| K152442 | ABBOTT LABORATORIES | Freestyle Freedom Blood Glucose Monitoring Sytem | 12/17/2015 |
| K150531 | Abbott Laboratories | FreeStyle Freedom Lite Blood Glucose Monitoring System | 06/05/2015 |
| K150332 | ABBOTT LABORATORIES | FreeStyle Lite Blood Glucose Monitoring System | 06/05/2015 |
| K022182 | ABBOTT LABORATORIES | MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM | 09/09/2002 |
| K040814 | ABBOTT LABORATORIES | MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM | 04/15/2004 |
| K040628 | ABBOTT LABORATORIES | PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM | 03/25/2004 |
| K033845 | ABBOTT LABORATORIES | PRECISION XCEED DIABETES MONITORING SYSTEM | 01/08/2004 |
| K010553 | ABBOTT LABORATORIES | PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY | 06/18/2001 |
| K023256 | ABBOTT LABORATORIES | PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO | 04/23/2003 |
| K012975 | ABBOTT LABORATORIES | SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS | 02/28/2002 |
| K051213 | ABBOTT LABORATORIES INC | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS | 05/27/2005 |
| K161867 | ACON LABORATORIES | On Call Pro Blood Glucose Monitoring System | 08/05/2016 |
| K090057 | ACON LABORATORIES CO. | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM | 04/08/2009 |
| K131469 | ACON LABORATORIES, INC. | ACON ON CALL DIABETES MANAGEMENT SOFTWARE | 01/06/2014 |
| K132086 | ACON LABORATORIES, INC. | ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | 12/19/2013 |
| K192175 | ACON Laboratories, Inc. | On Call Express II Blood Glucose Monitoring System | 10/17/2019 |
| K180196 | ACON Laboratories, Inc. | On Call Express Mobile Blood Glucose Monitoring System | 03/07/2018 |
| K151595 | ACON Laboratories, Inc. | On Call Express Pro Blood Glucose Monitoring System | 09/05/2015 |
| K191038 | ACON Laboratories, Inc. | On Call Express Voice Blood Glucose Monitoring System | 06/12/2019 |
| K101371 | ACON LABORATORIES, INC. | ON CALL PLUS DIABETES MONITORING SOFTWARE | 01/07/2011 |
| K130284 | ACON LABORATORIES, INC. | ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM | 12/20/2013 |
| K181527 | ACON Laboratories, Inc. | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | 10/03/2018 |
| K123010 | ACON LABORATORIES, INC. | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM | 12/14/2012 |
| K071393 | AGAMATRIX | JAZZ BLOOD GLUCOSE MONITORING SYSTEM | 07/20/2007 |
| K063409 | AGAMATRIX | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | 01/12/2007 |
| K072413 | AGAMATRIX | MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM | 09/27/2007 |
| K101597 | AGAMATRIX | WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 | 10/18/2010 |
| K073573 | AGAMATRIX | WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM | 01/30/2008 |
| K062434 | AGAMATRIX | ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 | 11/13/2006 |
| K132821 | AGAMATRIX INC | AGAMATRIX HEALTH MANAGER | 11/20/2013 |
| K130535 | AGAMATRIX INC | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION | 04/17/2013 |
| K103544 | AGAMATRIX INC | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D | 12/07/2011 |
| K083265 | AGAMATRIX INC | JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 | 02/03/2009 |
| K052762 | AGAMATRIX INC | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | 01/23/2006 |
| K152365 | AgaMatrix, Inc. | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | 04/21/2016 |
| K161834 | AgaMatrix, Inc. | One Drop Blood Glucose Monitoring System | 11/30/2016 |
| K083628 | ALL MEDICUS CO., LTD | GLUCODR AUTO SYSTEM | 05/01/2009 |
| K082328 | ALL MEDICUS CO., LTD | GLUCODR PLUS SYSTEM, MODEL AGM-3000 | 02/27/2009 |
| K050985 | ALL MEDICUS CO., LTD | GLUCODR SUPERSENSOR SYSTEM | 10/07/2005 |
| K130657 | ALL MEDICUS CO., LTD | LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE | 07/15/2013 |
| K170241 | All Medicus Co., Ltd. | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | 10/13/2017 |
| K132663 | ALLIANCE INTERNATIONAL CO., LTD. | I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM | 04/20/2015 |
| K102063 | ALR TECHNOLOGIES | HEALTH-E-CONNECT SYSTEM | 10/11/2011 |
| K043543 | AMERICAN HEALTHCARE INC. | BLOOD GLUCOSE MONITORING SYSTEM | 04/08/2005 |
| K031501 | AMERICAN HEALTHCARE INC. | EASYGLUCO, MODEL IGM0002 | 10/16/2003 |
| K153561 | ANDON HEALTH CO., LTD | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System | 02/16/2017 |
| K153286 | Andon health Co., Ltd | iHealth Align Gluco-Monitoring system | 08/19/2016 |
| K170231 | Andon health Co., Ltd | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á | 09/15/2017 |
| K133790 | ANDON HEALTH CO., LTD | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | 05/22/2014 |
| K181070 | Andon health Co., Ltd | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | 02/01/2019 |
| K153278 | Andon Health Co., Ltd | Wireless Smart Gluco-Monitoring System | 08/19/2016 |
| K073030 | ANDON HEALTH CO.,LTD | AG-605 BLOOD GLUCOSE MONITORING SYSTEM | 07/21/2008 |
| K150833 | ANDON HEALTH CO.,LTD | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System | 12/04/2015 |
| K120813 | ANDON MEDICAL CO., LTD | BLOOD GLUCOSE MONITORING SYSTEM | 12/07/2012 |
| K093262 | ANDON MEDICAL CO., LTD. | AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM | 07/13/2010 |
| K110017 | ANDON MEDICAL CO., LTD. | AG-608N BLOOD GLUCOSE MONITORING SYSTEM | 01/18/2012 |
| K093755 | ANDON MEDICAL CO., LTD. | AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM | 07/15/2011 |
| K112738 | ANDON MEDICAL CO., LTD. | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE | 09/30/2011 |
| K102678 | ANDON MEDICAL CO., LTD. | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | 08/26/2011 |
| K101307 | ANDON MEDICAL CO., LTD. | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 | 08/09/2011 |
| K123935 | ANDON MEDICAL CO., LTD. | IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM | 04/12/2013 |
| K120649 | APEX BIO TECHNOLOGY CORP | AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM | 07/06/2012 |
| K170267 | Apex Bio Technology Corp. | BGM009 Plus Blood Glucose Monitoring System | 03/09/2017 |
| K070088 | APEX BIOTECHNOLOGY CORP. | ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM | 02/16/2007 |
| K102481 | APEX BIOTECHNOLOGY CORP. | AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP | 04/28/2011 |
| K150396 | APEX BIOTECHNOLOGY CORP. | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips | 10/14/2015 |
| K113098 | APEX BIOTECHNOLOGY CORP. | AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III | 01/17/2012 |
| K141036 | APEX BIOTECHNOLOGY CORP. | BGM009 BLOOD GLUCOSE MONITORING SYSTEM | 05/01/2015 |
| K182992 | Apex Biotechnology Corp. | BGM014 Blood Glucose Monitoring System | 11/28/2018 |
| K161299 | APEX BIOTECHNOLOGY CORP. | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System | 12/23/2016 |
| K220421 | Apex BioTechnology Corp. | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | 11/04/2022 |
| K213887 | Apex BioTechnology Corp. | GAL-1A Plus Blood Glucose Monitoring System | 03/29/2022 |
| K102816 | APEX BIOTECHNOLOGY CORP. | GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS | 09/15/2011 |
| K222234 | Apex BioTechnology Corp. | GlucoSure ADVANCE Link Blood Glucose Monitoring System | 12/21/2022 |
| K202885 | Apex BioTechnology Corp. | GlucoSure HT Plus Blood Glucose Monitoring System | 09/15/2021 |
| K212140 | Apex Biotechnology Corp. | GlucoSure Link Blood Glucose Monitoring System | 08/25/2022 |
| K073137 | APEX BIOTECHNOLOGY CORP. | GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 | 04/01/2008 |
| K202534 | Apex Biotechnology Corp. | MTM301 Blood Glucose and Ketone Monitoring System | 04/06/2022 |
| K201880 | Apex Biotechnology Corp. | MultiSure GK Link Blood Glucose and Ketone Monitoring System | 10/15/2021 |
| K173658 | Applied Biomedical LLC | Confidence Blood Glucose Monitoring System | 08/21/2018 |
| K142035 | ARKRAY FACTORY INC. | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | 09/05/2014 |
| K110709 | ARKRAY Factory USA, Inc. | ARK CARE DIABETES MANAGMENT SYSTEM | 05/19/2011 |
| K093819 | ARKRAY Factory USA, Inc. | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | 06/09/2010 |
| K090332 | ARKRAY Factory USA, Inc. | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | 08/14/2009 |
| K063771 | ARKRAY Factory USA, Inc. | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | 08/09/2007 |
| K090653 | ARKRAY Factory USA, Inc. | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | 10/09/2009 |
| K170064 | ARKRAY FACTORY, INC. | GLUCOCARD W Blood Glucose Monitoring System | 08/16/2017 |
| K183306 | ARKRAY Factory, Inc. | GLUCOCARD« W onyx Blood Glucose Monitoring System | 04/10/2019 |
| K063068 | ARKRAY USA, INC. | FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 | 12/20/2006 |
| K160682 | ASCENSIA DIABETES CARE | CONTOUR NEXT ONE Blood Glucose Monitoring System | 11/17/2016 |
| K191286 | Ascensia Diabetes Care | CONTOUR« NEXT Blood Glucose Monitoring System, CONTOUR« NEXT USB Blood Glucose Monitoring System, CONTOUR« NEXT ONE Blood Glucose Monitoring System, CONTOUR« NEXT EZ Blood Glucose Monitoring System, CONTOUR« NEXT LINK Wireless Blood Glucose Monitoring Sys | 11/08/2019 |
| K193407 | Ascensia Diabetes Care | Contour« next GEN Blood Glucose Monitoring System | 12/23/2021 |
| K210687 | Ascensia Diabetes Care | CONTOUR« NEXT ONE Blood Glucose Monitoring System | 08/11/2021 |
| K162336 | Ascensia Diabetes Care US Inc. | Contour Next EZ Blood Glucose Monitoring System | 01/12/2017 |
| K160430 | Ascensia Diabetes Care US Inc. | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | 06/24/2016 |
| K223293 | Ascensia Diabetes Care US Inc. | CONTOUR« NEXT GEN Blood Glucose Monitoring System | 11/18/2022 |
| K023584 | BAYER CORP. | ASCENSIA DEX 2 DIABETES CARE SYSTEM | 11/20/2002 |
| K024234 | BAYER CORP. | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | 01/23/2003 |
| K012205 | BAYER CORP. | GLUCOMETER DEX TEST SENSOR | 09/12/2001 |
| K020210 | BAYER GROUP DIAGNOSTICS | GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) | 04/30/2002 |
| K020208 | BAYER GROUP DIAGNOSTICS | GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) | 04/29/2002 |
| K060470 | BAYER HEALTHCARE | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 | 04/12/2006 |
| K062058 | BAYER HEALTHCARE | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 | 09/11/2006 |
| K122370 | BAYER HEALTHCARE | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR | 09/26/2013 |
| K121087 | BAYER HEALTHCARE | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM | 06/28/2012 |
| K150942 | BAYER HEALTHCARE | Contour Next USB Blood Glucose Monitoring System | 11/25/2015 |
| K091820 | BAYER HEALTHCARE | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM | 08/26/2009 |
| K130265 | BAYER HEALTHCARE LLC | CONTOUR NEXT EZ BLOOD GLUCOSE METER | 06/23/2014 |
| K093930 | BAYER HEALTHCARE LLC | DIDGET WORLD REPORTS | 03/12/2010 |
| K062347 | BAYER HEALTHCARE, LLC | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM | 11/22/2006 |
| K043158 | BAYER HEALTHCARE, LLC | ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM | 12/22/2004 |
| K043311 | BAYER HEALTHCARE, LLC | ASCENSIA ELITE DIABETES CARE SYSTEM | 12/22/2004 |
| K090628 | BAYER HEALTHCARE, LLC | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 | 12/04/2009 |
| K082486 | BAYER HEALTHCARE, LLC | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | 10/08/2008 |
| K023219 | BECTON DICKINSON & CO. | BECTON DICKINSON DIABETES SOFTWARE | 12/06/2002 |
| K022581 | BECTON DICKINSON & CO. | BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM | 10/09/2002 |
| K040603 | BECTON DICKINSON & CO. | PARADIGM LINK BLOOD GLUCOSE METER | 05/19/2004 |
| K090389 | BESTGEN BIOTECH CORP. | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM | 07/14/2009 |
| K100437 | BESTGEN BIOTECH CORP. | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION | 01/12/2012 |
| K103044 | BESTGEN BIOTECH CORP. | AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | 02/10/2012 |
| K072274 | BESTGEN BIOTECH CORP. | MAJOR III BLOOD GLUCOSE MONITORING SYSTEM | 02/29/2008 |
| K122307 | BIOCARE CORPORATION | DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM | 04/05/2013 |
| K191657 | Bioland Technology Ltd. | Bioland Blood Glucose Monitoring System | 03/20/2020 |
| K202739 | Bioland Technology Ltd. | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | 08/12/2022 |
| K143387 | Bionime Coporation | GE333 Blood Glucose Monitoring System | 06/03/2015 |
| K141292 | BIONIME COPORATION | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System | 06/09/2015 |
| K133522 | BIONIME COPORATION | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM | 04/17/2014 |
| K120423 | BIONIME CORPORATION | BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 | 08/03/2012 |
| K170143 | Bionime Corporation | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | 07/06/2017 |
| K161790 | BIONIME CORPORATION | iGlucose Blood Glucose Monitoring System | 05/02/2017 |
| K053635 | BIONIME CORPORATION | MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | 02/21/2006 |
| K042678 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | 01/03/2005 |
| K062567 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | 02/16/2007 |
| K140210 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | 08/22/2014 |
| K110737 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 | 03/29/2012 |
| K123008 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN | 01/25/2013 |
| K190564 | Bionime Corporation | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | 06/02/2019 |
| K173638 | Bionime Corporation | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | 08/17/2018 |
| K173139 | Bionime Corporation | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | 06/19/2018 |
| K081451 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 | 09/18/2008 |
| K081450 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 | 09/11/2008 |
| K072054 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 | 02/28/2008 |
| K092052 | BIONIME CORPORATION | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 | 06/18/2010 |
| K053312 | BIOPTIK TECHNOLOGY, INC. | EASYMATE BLOOD GLUCOSE MONITORING SYSTEM | 03/01/2006 |
| K133509 | Biotest Medical Corp. | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | 02/21/2014 |
| K100560 | Biotest Medical Corp. | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | 05/12/2010 |
| K122525 | Biotest Medical Corp. | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM | 05/02/2013 |
| K100701 | Biotest Medical Corp. | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | 04/08/2010 |
| K093764 | Biotest Medical Corp. | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | 03/02/2010 |
| K123559 | Biotest Medical Corp. | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | 06/28/2013 |
| K091815 | Biotest Medical Corp. | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | 11/16/2009 |
| K141351 | Biotest Medical Corp. | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | 05/19/2015 |
| K171822 | Biotest Medical Corporation | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | 09/20/2017 |
| K171785 | Biotest Medical Corporation | WowGoHealth Blood Glucose Monitoring System | 09/15/2017 |
| K120183 | BROADMASTER BIOTECH CORPERATION | ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM | 05/11/2012 |
| K130621 | BROADMASTER BIOTECH CORPORATION | BROADMASTER HEALTHCARE SYSTEM | 07/30/2013 |
| K032029 | BT MEDICAL | BTG SMARTEST GLUCOSE TEST SYSTEM | 12/18/2003 |
| K102383 | CAMBRIDGE SENSORS LIMITED | MICRODOT & MICRODOT XTRA | 01/27/2012 |
| K070524 | CAMBRIDGE SENSORS LIMITED | MICRODOT BLOOD GLUCOSE MONITORING SYSTEM | 06/22/2007 |
| K083273 | CAMBRIDGE SENSORS LIMITED | MICRODOT XTRA | 11/19/2009 |
| K082521 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM | 01/16/2009 |
| K141829 | CERAGEM MEDISYS INC. | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | 09/24/2014 |
| K140141 | CERAGEM MEDISYS INC. | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | 07/03/2014 |
| K102751 | CERAGEM MEDISYS INC. | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | 02/11/2013 |
| K010039 | CHRONIMED, INC. | QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION | 08/10/2001 |
| K131363 | CILAG GMBH INTERNATIONAL | ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | 08/30/2013 |
| K120708 | CILAG GMBH INTERNATIONAL | ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM | 02/07/2013 |
| K120866 | DELBIO INCORPORATION | DA01 BLOOD GLUCOSE MONITORING SYSTEM | 12/11/2012 |
| K132338 | DELBIO INCORPORATION | DA01 BLOOD GLUCOSE MONITORING SYSTEM | 10/24/2013 |
| K100806 | DELBIO INCORPORATION | DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM | 09/16/2011 |
| K113343 | DELBIO INCORPORATION | DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM | 02/08/2012 |
| K130244 | DELBIO INCORPORATION | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM | 08/23/2013 |
| K103329 | DELBIO INCORPORATION | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION | 03/13/2012 |
| K062538 | DIACARE CORP. | EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM | 04/30/2007 |
| K053593 | DIAGNOSTIC DEVICES INC. | PRODIGY | 07/06/2006 |
| K073118 | DIAGNOSTIC DEVICES INC. | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM | 03/05/2008 |
| K060467 | DIAGNOSTIC DEVICES, INC. | PRODIGY BLOOD GLUCOSE TEST SYSTEM | 07/13/2006 |
| K052343 | E-SAN LIMITED | E-SAN BLUETOOTH CRADLE | 12/07/2005 |
| K061328 | E-SAN LIMITED | THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) | 06/13/2006 |
| K143169 | ENTRA HEALTH SYSTEMS | MyGlucoHealth Wireless System | 01/08/2016 |
| K081703 | ENTRA HEALTH SYSTEMS, LTD. | MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS | 01/08/2009 |
| K182057 | EPS Bio Technology Corp. | EasyMax BT Self-Monitoring Blood Glucose System | 08/24/2018 |
| K083099 | EPS BIO TECHNOLOGY CORP. | EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 | 01/16/2009 |
| K102345 | EPS BIO TECHNOLOGY CORP. | EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 | 06/21/2011 |
| K201258 | EPS Bio Technology Corp. | EASYMAX Tag Self-Monitoring Blood Glucose System | 09/01/2021 |
| K092894 | EPS BIO TECHNOLOGY CORP. | EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM | 02/24/2010 |
| K092887 | EPS BIO TECHNOLOGY CORP. | EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 | 10/21/2009 |
| K091481 | EPS BIO TECHNOLOGY CORP. | EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM | 08/18/2009 |
| K081796 | EPS BIO TECHNOLOGY CORP. | EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM | 01/23/2009 |
| K101457 | EPS BIO TECHNOLOGY CORP. | EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 | 07/01/2010 |
| K070053 | EPS BIO TECHNOLOGY CORP. | EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 | 12/03/2007 |
| K133389 | EPS BIO TECHNOLOGY CORP. | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | 04/15/2014 |
| K133647 | EPS BIO TECHNOLOGY CORP. | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | 02/27/2014 |
| K091229 | EPS BIO TECHNOLOGY CORP. | GLUCOMANAGER DATA MANAGEMENT SOFTWARE | 07/31/2009 |
| K190189 | EPS Bio Technology Corp. | MDT2 BLE Self-Monitoring Blood Glucose System | 11/01/2019 |
| K040678 | EUMED BIOTECHNOLOGY CO., LTD. | EUSURE BLOOD GLUCOSE MONITORING SYSTEM | 07/14/2004 |
| K070239 | EXIR PHARMACEUTICAL CO. | MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM | 05/25/2007 |
| K173505 | ForaCare Inc. | FORA GTel Blood Glucose Monitoring System | 08/09/2018 |
| K123090 | GENERAL LIFE BIOTECHNOLOGY CO., LTD. | GLB BENECHECK PREMIUM GLU MONITORING SYSTEM | 11/22/2013 |
| K123136 | GENESIS HEALTH TECHNOLOGIES | GENESIS HEALTH RECORD SYSTEM, (GHRS) | 03/07/2013 |
| K080853 | GENEXEL-SEIN, INC. | DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM | 02/20/2009 |
| K132272 | GLOOKO, INC. | GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION | 10/17/2013 |
| K130886 | GLOOKO, INC. | GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION | 04/25/2013 |
| K122142 | GLOOKO, INC. | GLOOKO LOGBOOK CHARTS | 12/21/2012 |
| K061234 | GLUCOPLUS INC | GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM | 10/30/2006 |
| K141862 | H2 Inc. | HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE | 12/02/2014 |
| K110074 | HEALTH & LIFE CO., LTD. | HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM | 05/25/2012 |
| K052469 | HEALTHPIA AMERICA CORP. | GLUCOPACK | 06/05/2006 |
| K212248 | HMD BioMedical Inc. | GlucoLeader Enhance 2 Blood Glucose Monitoring System | 08/29/2022 |
| K182428 | HMD BioMedical Inc. | GlucoLeader Enhance Blood Glucose Monitoring System | 05/08/2019 |
| K072369 | HMD BIOMEDICAL LLC | EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM | 03/21/2008 |
| K131173 | HMD BIOMEDICAL, INC. | FIA Blood Glucose Monitoring System (G2) | 09/18/2014 |
| K032985 | HMD BIOMEDICAL, INC. | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM | 10/21/2003 |
| K023279 | HMD BIOMEDICAL, INC. | GLUCOLEADER VALUE | 08/04/2003 |
| K140150 | HMD BIOMEDICAL, INC. | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System | 05/14/2015 |
| K120064 | HMD BIOMEDICAL, INC. | TEST, BLOOD GLUCOSE SYSTEM | 09/05/2012 |
| K060793 | HOME DIAGNOSTICS, INC. | ELEMENT BLOOD GLUCOSE TEST SYSTEM | 07/25/2006 |
| K040670 | HOME DIAGNOSTICS, INC. | MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL | 03/25/2004 |
| K010403 | HOME DIAGNOSTICS, INC. | PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 | 03/26/2001 |
| K051147 | HOME DIAGNOSTICS, INC. | SIDEKICK BLOOD GLUCOSE TEST SYSTEM | 07/12/2005 |
| K070593 | HOME DIAGNOSTICS, INC. | TRACKRECORD DATA MANAGEMENT SOFTWARE | 05/07/2007 |
| K080710 | HOME DIAGNOSTICS, INC. | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 | 08/13/2008 |
| K090495 | HOME DIAGNOSTICS, INC. | TRUEBALANCE BLOOD GLUCOSE SYSTEM | 03/27/2009 |
| K080641 | HOME DIAGNOSTICS, INC. | TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 | 08/19/2008 |
| K030703 | HOME DIAGNOSTICS, INC. | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS | 07/11/2003 |
| K032657 | HOME DIAGNOSTICS, INC. | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) | 03/24/2004 |
| K093475 | HYGEIA, INC. | BASESENS BLOOD GLUCOSE MONITORING SYSTEM | 02/24/2010 |
| K051514 | HYPOGUARD USA, INC. | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 | 10/04/2005 |
| K022545 | HYPOGUARD USA, INC. | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 | 10/11/2002 |
| K131419 | i-SENS, Inc. | ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | 08/09/2013 |
| K151164 | i-Sens, Inc. | Assure Prism multi Blood Glucose Monitoring System | 08/07/2015 |
| K080923 | i-SENS, Inc. | CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB | 10/17/2008 |
| K083468 | i-SENS, Inc. | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) | 02/10/2009 |
| K201394 | i-SENS, Inc. | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | 10/05/2021 |
| K130696 | i-SENS, Inc. | CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM | 08/21/2013 |
| K120351 | i-SENS, Inc. | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | 05/03/2012 |
| K170614 | i-SENS, Inc. | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | 10/19/2017 |
| K121133 | i-SENS, Inc. | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM | 07/10/2012 |
| K132288 | i-SENS, Inc. | CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER | 11/22/2013 |
| K192859 | i-SENS, Inc. | CareSens S Clear BT Blood Glucose Monitoring System | 01/24/2020 |
| K180866 | i-SENS, Inc. | CareSens S Fit Blood Glucose Monitoring System | 08/31/2018 |
| K193590 | i-SENS, Inc. | CareSens S Fit BT Blood Glucose Monitoring System | 01/17/2020 |
| K103396 | i-SENS, Inc. | COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION | 09/27/2011 |
| K181273 | i-SENS, Inc. | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | 11/01/2018 |
| K160742 | i-SENS, INC. | NoCoding1 Plus Blood Glucose Monitoring System | 12/16/2016 |
| K171480 | i-SENS, Inc. | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | 12/13/2017 |
| K100937 | i-SENS, Inc. | PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE | 12/21/2010 |
| K230625 | i-SENS, Inc. | ReliOn Premier BLU Blood Glucose Monitoring System | 08/10/2023 |
| K192220 | i-SENS, Inc. | ReliOn Premier Classic Blood Glucose Monitoring System | 12/13/2019 |
| K133346 | i-SENS, Inc. | SMARTLOG DIABETES MANAGEMENT SOFTWARE | 12/19/2013 |
| K132180 | IDEAL LIFE INC. | IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM | 06/25/2014 |
| K080538 | IDEAL LIFE INC. | IDEAL LIFE POD (MODEL ILP 0001) | 07/03/2008 |
| K103021 | INFOPIA CO., LTD | ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM | 11/04/2011 |
| K133045 | INFOPIA CO., LTD | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM | 04/10/2014 |
| K132406 | INFOPIA CO., LTD | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM | 04/18/2014 |
| K082020 | INFOPIA CO., LTD | ENVISION BLOOD GLUCOSE TEST SYSTEM | 12/24/2008 |
| K090712 | INFOPIA CO., LTD | EOCENE SYSTEM | 10/02/2009 |
| K091157 | INFOPIA CO., LTD | GLUCO LAB AUTO CODING, MODEL IGM-0022 | 11/17/2009 |
| K091168 | INFOPIA CO., LTD | GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 | 05/27/2010 |
| K130181 | INFOPIA CO., LTD | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | 07/31/2013 |
| K132966 | INFOPIA CO., LTD | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | 12/05/2013 |
| K113192 | INFOPIA CO., LTD | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | 07/13/2012 |
| K132862 | INFOPIA CO., LTD | HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | 12/12/2013 |
| K130295 | INFOPIA CO., LTD | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | 06/21/2013 |
| K090405 | INFOPIA CO., LTD | LIPIDPRO SYSTEM | 12/01/2009 |
| K160365 | Infopia Co., Ltd. | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | 09/28/2016 |
| K150274 | Infopia Co., Ltd. | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | 08/26/2015 |
| K152493 | INTUITY MEDICAL, INC | POGO Automatic Blood Glucose Monitoring System | 04/25/2016 |
| K181316 | Intuity Medical, Inc. | POGO Automatic Blood Glucose Monitoring System | 06/14/2018 |
| K162203 | Intuity Medical, Inc. | POGO Automatic Blood Glucose Monitoring System | 04/06/2017 |
| K011616 | INVERNESS MEDICAL INNOVATIONS, INC. | INDUO BLOOD GLUCOSE METER | 06/21/2001 |
| K163087 | iXensor Company Ltd. | PixoTest Blood Glucose Monitoring System | 11/02/2017 |
| K140325 | JOINSOON MEDICAL TECHNOLOGY CO, LTD. | Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System | 10/13/2015 |
| K172723 | LabStyle Innovation, Ltd. | Dario LC Blood Glucose Monitoring System | 03/23/2018 |
| K150817 | LabStyle Innovations Ltd. | Dario Blood Glucose Monitoring System | 12/21/2015 |
| K163159 | LabStyle Innovations, Ltd. | Dario Blood Glucose Monitoring System | 07/19/2017 |
| K151611 | LIFESCAN EUROPE | OneTouch Ultra Plus Flex Blood Glucose Monitoring System | 12/14/2015 |
| K150214 | LIFESCAN EUROPE | OneTouch Verio Flex Blood Glucose Monitoring System | 07/31/2015 |
| K193475 | LifeScan Europe GmbH | OneTouch Verio Reflect Blood Glucose Monitoring System | 02/14/2020 |
| K062195 | LIFESCAN, INC. | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | 08/16/2006 |
| K024194 | LIFESCAN, INC. | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS | 02/07/2003 |
| K021819 | LIFESCAN, INC. | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | 08/23/2002 |
| K093745 | LIFESCAN, INC. | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | 02/11/2011 |
| K120558 | LIFESCAN, INC. | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION | 02/07/2013 |
| K072543 | LIFESCAN, INC. | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | 10/05/2007 |
| K053529 | LIFESCAN, INC. | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | 01/17/2006 |
| K073231 | LIFESCAN, INC. | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | 04/18/2008 |
| K061118 | LIFESCAN, INC. | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | 05/19/2006 |
| K082513 | LIFESCAN, INC. | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM | 10/22/2008 |
| K081318 | LIFESCAN, INC. | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | 06/09/2008 |
| K022724 | LIFESCAN, INC. | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | 09/12/2002 |
| K023832 | LIFESCAN, INC. | SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | 12/13/2002 |
| K200277 | Livongo Health, Inc. | Livongo Blood Glucose Monitoring System (BG1000) | 06/04/2020 |
| K062377 | MEDAPPS, INC. | MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 | 07/03/2007 |
| K011240 | MEDLINE INDUSTRIES, INC. | EVENCARE BLOOD GLUCOSE MONITORING SYSTEM | 09/13/2001 |
| K031843 | MEDLINE INDUSTRIES, INC. | MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM | 07/03/2003 |
| K123007 | MICOBIOMED CO, LTD | VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM | 06/19/2013 |
| K123016 | MICOBIOMED CO, LTD | VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS | 06/18/2013 |
| K193340 | MicroTech Medical, Inc. | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System | 09/11/2020 |
| K223722 | Mio Labs Inc. | MIO Blood Glucose Monitoring System | 06/28/2023 |
| K073699 | MYCARE TEAM, INC. | MCT-DIABETES | 03/26/2008 |
| K062187 | NATIONAL DIAGNOSTIC PRODUCTS | BETACHEK GLUCOSE TEST | 03/24/2009 |
| K050224 | NEUERO ENGINEERING INC. | 3TEST GLUCOSE MONITORING SYSTEM | 07/13/2005 |
| K072905 | NEUERO ENGINEERING INC. | 3TEST SUPREME GLUCOSE MONITORING SYSTEM | 04/18/2008 |
| K150052 | Nipro Diagnostics, Inc | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | 03/26/2015 |
| K132072 | NIPRO DIAGNOSTICS, INC. | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | 08/15/2013 |
| K140100 | NIPRO DIAGNOSTICS, INC. | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | 08/01/2014 |
| K120989 | NIPRO DIAGNOSTICS, INC. | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | 04/24/2013 |
| K070255 | NOVA BIOMEDICAL CORP. | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 | 06/13/2007 |
| K091547 | NOVA BIOMEDICAL CORP. | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS | 01/15/2010 |
| K131013 | NOVA BIOMEDICAL CORPORATION | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | 10/17/2013 |
| K112638 | NOVA BIOMEDICAL CORPORATION | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS | 03/09/2012 |
| K160156 | NOVA BIOMEDICAL CORPORATION | StatStrip Xpress Blood Glucose Monitoring System | 06/23/2016 |
| K170464 | Nova Biomedical Corporation | StatStrip Xpress Blood Glucose Monitoring System | 11/07/2017 |
| K063026 | OK BIOTECH CO., LTD. | OK METER BLOOD GLUCOSE MONITORING SYSTEM | 02/09/2007 |
| K132633 | OK BIOTECH CO., LTD. | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | 08/14/2014 |
| K090609 | OK BIOTECH CO., LTD. | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | 02/04/2010 |
| K152599 | OK BIOTECH CO., LTD. | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | 07/20/2016 |
| K141914 | OK BIOTECH CO., LTD. | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | 04/15/2015 |
| K142785 | OK BIOTECH CO., LTD. | PRODIGY iConnect Blood Glucose Monitoring System | 12/17/2015 |
| K213061 | OK BioTech Co., Ltd. | SuperCheck Pro Blood Glucose Monitoring System | 10/07/2022 |
| K160038 | OK BIOTECH CO., LTD. | UniStrip1 Generic Blood Glucose Test Strips | 07/29/2016 |
| K162430 | OK BIOTECH CO., LTD. | UniStrip1 Generic Blood Glucose Test Strips | 01/19/2017 |
| K203562 | Osang Healthcare Co., Ltd. | Finetest Lite Blood Glucose Monitoring System | 07/13/2021 |
| K201396 | OSANG Healthcare Co., Ltd. | Finetest Lite Smart Blood Glucose Monitoring System | 10/16/2020 |
| K182286 | OSANG Healthcare Co., Ltd. | Oh'Care Lite Smart Blood Glucose Monitoring System | 09/19/2018 |
| K141656 | Philosys Inc. | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM | 10/02/2015 |
| K151658 | Philosys Inc. | Gmate Origin Blood Glucose Monitoring System | 12/01/2015 |
| K150299 | Philosys Inc. | Gmate SMART Blood Glucose Monitoring System | 11/19/2015 |
| K131230 | PHILOSYS, INC. | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION | 08/04/2014 |
| K070559 | POLYMAP WIRELESS | POLYMAP PWR-08-03 | 06/29/2007 |
| K091296 | POLYMAP WIRELESS | POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 | 07/17/2009 |
| K014167 | POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM | 02/19/2002 |
| K013203 | POLYMER TECHNOLOGY SYSTEMS, INC. | BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS | 11/16/2001 |
| K014099 | POLYMER TECHNOLOGY SYSTEMS, INC. | BIOSCANNER PLUS | 12/21/2001 |
| K140068 | POLYMER TECHNOLOGY SYSTEMS, INC. | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | 05/22/2015 |
| K041750 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS CHOL+GLU TEST PANEL | 07/23/2004 |
| K071507 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | 09/10/2007 |
| K070017 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | 01/31/2007 |
| K193406 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics | CardioChek Plus Test System; CardioChek Plus Home Test System | 02/26/2022 |
| K111932 | POSITIVEID CORPORATION | IGLUCOSE SYSTEM | 11/10/2011 |
| K122338 | PRODIGY DIABETES CARE, LLC | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM | 11/05/2013 |
| K122340 | PRODIGY DIABETES CARE, LLC | PRODIGY CHOICE | 11/26/2013 |
| K103115 | PRODIGY DIABETES CARE, LLC. | PRODIGY DIABETES MANAGEMENT SOFTWARE | 10/12/2011 |
| K181131 | Roche Diabetes Care | Accu-Chek Guide Me Blood Glucose Monitoring System | 12/13/2018 |
| K213131 | Roche Diabetes Care GmbH | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | 08/10/2023 |
| K203711 | Roche Diabetes Care Inc. | IWL2020 Blood Glucose Monitoring System | 05/06/2022 |
| K160944 | Roche Diabetes Care, Inc. | ACCU-CHEK Guide Blood Glucose Monitoring System | 08/31/2016 |
| K113614 | Roche Diagnostics | ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM | 02/12/2013 |
| K141867 | Roche Diagnostics | ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM | 03/03/2015 |
| K081389 | Roche Diagnostics | ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM | 07/15/2008 |
| K121679 | Roche Diagnostics | ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM | 10/11/2012 |
| K133741 | Roche Diagnostics | ACCU-CHEK Performa Blood Glucose Monitoring System | 08/29/2014 |
| K113137 | Roche Diagnostics | GLUCOSE TEST SYSTEM | 01/06/2012 |
| K011738 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ACTIVE SYSTEM | 06/20/2001 |
| K012324 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ACTIVE TEST SYSTEM | 12/05/2001 |
| K021513 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ADVANTAGE MODULE | 06/11/2002 |
| K032552 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ADVANTAGE SYSTEM | 09/12/2003 |
| K060620 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK AVIVA TEST STRIPS | 08/11/2006 |
| K022171 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK COMPACT SYSTEM | 07/23/2002 |
| K070585 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK PERFORMA SYSTEM | 05/25/2007 |
| K062395 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK SMART PIX | 05/09/2007 |
| K021827 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM | 07/03/2002 |
| K021448 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM | 06/03/2002 |
| K012210 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO ACCU-CHEK INFORM METER | 08/09/2001 |
| K130138 | ROCHE DIAGNOSTICS CORP. | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | 03/15/2013 |
| K133862 | ROCHE DIAGNOSTICS CORPORATION | ACCU-CHEK AVIVA PLUS SYSTEM | 04/29/2014 |
| K131029 | ROCHE DIAGNOSTICS OPERATIONS INC | ACCU-CHEK AVIVA PLUS TEST STRIP | 08/09/2013 |
| K123517 | SD BIOSENSOR | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM | 01/17/2014 |
| K153201 | SD BIOSENSOR | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System | 06/24/2016 |
| K151265 | SD BIOSENSOR | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | 11/24/2015 |
| K160282 | SD BIOSENSOR | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System | 10/17/2017 |
| K132929 | SD BIOSENSOR, INC. | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM | 08/05/2015 |
| K052108 | SEIN ELECTRONICS CO., LTD. | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 | 12/07/2005 |
| K103542 | SHASTA TECHNOLOGIES, LLC | GENSTRIP TEST STRIP MODEL 100-201 | 11/30/2012 |
| K170264 | Sinocare Meditech, Inc. | Gold AQ Blood Glucose Monitoring System | 10/05/2017 |
| K082683 | STANDARD DIAGNOSTICS, INC. | SD CHECK GOLD | 12/08/2009 |
| K100398 | STANDARD DIAGNOSTICS, INC. | SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM | 06/09/2010 |
| K111509 | SWEETSPOT DIABETES CARE, INC. | SWEETSPOT DIABETES DATA MANAGEMENT SERVICE | 11/09/2011 |
| K093789 | SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC | INTOUCH DIABETES | 02/19/2010 |
| K083263 | SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC | SYMCARE DIABETES MANAGEMENT PROGRAM | 03/13/2009 |
| K061181 | TaiDoc Technology Corporation | ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 | 07/06/2006 |
| K042005 | TaiDoc Technology Corporation | ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 | 08/27/2004 |
| K173511 | TaiDoc Technology Corporation | ActiveCare TD-4121 Blood Glucose Monitoring System | 07/12/2018 |
| K070641 | TaiDoc Technology Corporation | ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 | 04/09/2007 |
| K093592 | TaiDoc Technology Corporation | ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 | 02/25/2010 |
| K072039 | TaiDoc Technology Corporation | ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F | 10/03/2007 |
| K093940 | TaiDoc Technology Corporation | ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 | 04/23/2010 |
| K113077 | TaiDoc Technology Corporation | BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM | 08/03/2012 |
| K091898 | TaiDoc Technology Corporation | BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 | 09/18/2009 |
| K051936 | TaiDoc Technology Corporation | CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS | 08/08/2005 |
| K081144 | TaiDoc Technology Corporation | CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 | 06/23/2008 |
| K073494 | TaiDoc Technology Corporation | CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING | 04/02/2008 |
| K090185 | TaiDoc Technology Corporation | CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM | 04/24/2009 |
| K070941 | TaiDoc Technology Corporation | CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 | 06/21/2007 |
| K073119 | TaiDoc Technology Corporation | CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM | 03/03/2008 |
| K042795 | TaiDoc Technology Corporation | CLEVER CHEK TD-3213 | 03/07/2005 |
| K062800 | TaiDoc Technology Corporation | CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO | 01/12/2007 |
| K080014 | TaiDoc Technology Corporation | CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | 06/09/2008 |
| K071493 | TaiDoc Technology Corporation | CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 | 10/26/2007 |
| K051854 | TaiDoc Technology Corporation | CLEVER CHEK TD-4225, MODEL TD-4225 | 08/05/2005 |
| K070472 | TaiDoc Technology Corporation | CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 | 03/15/2007 |
| K063212 | TaiDoc Technology Corporation | CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM | 11/22/2006 |
| K102049 | TaiDoc Technology Corporation | CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM | 05/27/2011 |
| K062235 | TaiDoc Technology Corporation | EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST | 09/19/2006 |
| K092875 | TaiDoc Technology Corporation | ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER | 08/13/2010 |
| K161738 | TAIDOC TECHNOLOGY CORPORATION | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ▀-Ketone Monitoring Systems | 11/10/2016 |
| K201037 | TaiDoc Technology Corporation | FORA ADVANCED GD40 Glucose, ▀-Ketone and Cholesterol Monitoring System | 06/16/2022 |
| K101926 | TaiDoc Technology Corporation | FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | 12/20/2011 |
| K111890 | TaiDoc Technology Corporation | FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM | 02/06/2012 |
| K090187 | TaiDoc Technology Corporation | FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 | 05/12/2009 |
| K100732 | TaiDoc Technology Corporation | FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 | 07/09/2010 |
| K094005 | TaiDoc Technology Corporation | FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM | 05/05/2010 |
| K093712 | TaiDoc Technology Corporation | FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM | 02/19/2010 |
| K093005 | TaiDoc Technology Corporation | FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 | 02/05/2010 |
| K101631 | TaiDoc Technology Corporation | FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM | 09/02/2011 |
| K143467 | TaiDoc Technology Corporation | FORA GD43 Blood Glucose Monitoring System | 05/07/2015 |
| K111029 | TaiDoc Technology Corporation | FORA POCT MANAGMENT SYSTEM | 07/01/2011 |
| K112275 | TaiDoc Technology Corporation | FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM | 12/15/2011 |
| K081715 | TaiDoc Technology Corporation | FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM | 12/17/2008 |
| K093035 | TaiDoc Technology Corporation | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 | 12/24/2009 |
| K090536 | TaiDoc Technology Corporation | FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 | 03/26/2009 |
| K124040 | TaiDoc Technology Corporation | FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM | 05/16/2013 |
| K090404 | TaiDoc Technology Corporation | FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 | 06/23/2009 |
| K110948 | TaiDoc Technology Corporation | HEALTH CARE SYSTEM SOFTWARE | 05/13/2011 |
| K080283 | TaiDoc Technology Corporation | IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM | 06/27/2008 |
| K091555 | TaiDoc Technology Corporation | MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | 03/15/2010 |
| K093635 | TaiDoc Technology Corporation | MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS | 02/18/2010 |
| K092099 | TaiDoc Technology Corporation | NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 | 12/10/2009 |
| K181588 | TaiDoc Technology Corporation | POPS! one Blood Glucose Monitoring System | 11/30/2018 |
| K082169 | TaiDoc Technology Corporation | PRO GLUCOSE TEST STRIP | 12/04/2008 |
| K072784 | TaiDoc Technology Corporation | PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM | 12/21/2007 |
| K072489 | TaiDoc Technology Corporation | REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM | 09/20/2007 |
| K162382 | TaiDoc Technology Corporation | Smart Dongle Blood Glucose Monitoring System | 04/14/2017 |
| K080501 | TaiDoc Technology Corporation | SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 | 04/21/2008 |
| K041107 | TaiDoc Technology Corporation | TAIDOC CHECK | 06/18/2004 |
| K190579 | TaiDoc Technology Corporation | TD-4183 Blood Glucose Monitoring System | 06/04/2019 |
| K101635 | TaiDoc Technology Corporation | TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM | 08/31/2011 |
| K112963 | TaiDoc Technology Corporation | TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | 11/22/2011 |
| K100322 | TaiDoc Technology Corporation | TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 | 06/28/2010 |
| K151100 | TAIDOC TECHNOLOGY CORPORATION | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System | 09/29/2015 |
| K090188 | TaiDoc Technology Corporation | U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 | 07/13/2009 |
| K092902 | TaiDoc Technology Corporation | U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC | 03/02/2010 |
| K081957 | TaiDoc Technology Corporation | U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM | 08/05/2008 |
| K101509 | TaiDoc Technology Corporation | U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM | 06/27/2011 |
| K082618 | TaiDoc Technology Corporation | ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 | 10/07/2008 |
| K110571 | TELCARE, INC. | TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE | 07/28/2011 |
| K111456 | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | 02/28/2012 |
| K133260 | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | 06/27/2014 |
| K152534 | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose M | 03/21/2017 |
| K162564 | Tianjin Empecs Medical Device Co.,Ltd. | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 | 06/07/2017 |
| K052208 | Tianjin New Bay Bioresearch Co., Ltd. | GLUCOSE PILOT | 12/09/2005 |
| K143548 | Trividia Health, Inc. | TRUE METRIX GO Self Monitoring Blood Glucose System | 04/01/2016 |
| K072854 | TYSON BIORESEARCH, INC. | DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM | 06/30/2008 |
| K062829 | TYSON BIORESEARCH, INC. | DIACHEX BLOOD GLUCOSE MONITORING SYSTEM | 10/10/2006 |
| K073492 | TYSON BIORESEARCH, INC. | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM | 04/08/2008 |
| K090629 | TYSON BIORESEARCH, INC. | EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS | 06/04/2009 |
| K072441 | TYSON BIORESEARCH, INC. | EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM | 03/25/2008 |
| K052818 | TYSON BIORESEARCH, INC. | EZ SMART-168 GLUCOSE MONITORING SYSTEM | 06/16/2006 |
| K182046 | Tyson Bioresearch, Inc. | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | 11/30/2018 |
| K170079 | TYSON BIORESEARCH, INC. | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | 10/06/2017 |
| K182047 | Tyson Bioresearch, Inc. | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | 11/29/2018 |
| K123087 | TYSON BIORESEARCH, INC. | TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM | 06/18/2013 |
| K101543 | TYSON BIORESEARCH, INC. | TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 | 08/30/2011 |
| K081726 | TYSON BIORESEARCH, INC. | TYSONBIO LINK HEALTH MANAGEMENT SYSTEM | 08/26/2008 |
| K112916 | TYSON BIORESEARCH, INC. | TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM | 08/21/2012 |
| K051651 | U. S. DIAGNOSTICS, INC. | G4, MODEL IGM-0004 | 04/14/2006 |
| K113135 | UNISTRIP TECHNOLOGIES, LLC | UNISTRIP 1 | 11/06/2013 |
| K110435 | US DIAGNOSTICS, INC. | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | 09/21/2011 |
| K082201 | US DIAGNOSTICS, INC. | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | 02/20/2009 |
| K043340 | VIP DIAGNOSTICS LLC | EZ SMART | 06/02/2005 |
| K040848 | VIP INTERNATIONAL WHOLESALERS, CORP. | EZ SMART | 08/11/2004 |
| K091765 | VISGENEER, INC. | EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM | 01/19/2010 |
| K122181 | VISGENEER, INC. | EBCHEK BLOOD GLUCOSE MONITORING SYSTEM | 08/15/2013 |
| K062555 | VISGENEER, INC. | EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G | 12/27/2006 |
| K160179 | VIVACHEK LABORATORIES, INC. | VivaChek Ino Blood Glucose Monitoring System | 04/21/2017 |
| K173140 | VivaChek Laboratories, Inc. | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitorin | 12/19/2018 |
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