FDA 510(k) Applications for Medical Device Product Code "CGA"
(Glucose Oxidase, Glucose)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103195 | ABBOTT POINT OF CARE INC. | I-STAT 1 WIRELESS ANALYZER | 02/08/2011 |
| K223710 | Abbott Point of Care Inc. | i-STAT CG8+ cartridge with the i-STAT 1 System | 07/28/2023 |
| K210958 | Abbott Point of Care Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 08/13/2021 |
| K223755 | Abbott Point of Care Inc. | i-STAT G cartridge with the i-STAT 1 System | 09/11/2023 |
| K163271 | Abbott Point of Care, Inc. | i-Stat Alinity System with i-Stat Glucose test | 04/10/2017 |
| K183678 | Abbott point of Care, Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 02/07/2020 |
| K122110 | ACON LABORATORIES, INC. | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM | 11/21/2012 |
| K111371 | ACON LABORATORIES, INC. | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM | 10/06/2011 |
| K960337 | ADVANCED MEDICAL DEVICES, INC. | AMD HOME HEALTH MONITORING SYSTEM | 09/24/1996 |
| K120615 | ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE | 05/15/2013 |
| K223179 | Alere San Diego, Inc. | Cholestech LDX Ö System | 09/20/2023 |
| K082965 | ALLIANCE INTERNATIONAL CO., LTD. | DS-A BLOOD GLUCOSE MONITORING SYSTEM | 12/07/2009 |
| K043512 | AMERICAN HEALTHCARE INC. | EASYGLUCO IGM-0002 G2 | 04/08/2005 |
| K982076 | AMIRA MEDICAL, INC. | AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM | 12/10/1998 |
| K010605 | AMIRA MEDICAL, INC. | ATLAST DATA MANAGEMENT SOFTWARE (DMS) | 05/07/2001 |
| K143750 | APEX BIO TECHNOLOGY CORP | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | 05/07/2015 |
| K131750 | APEX BIOTECHNOLOGY CORP. | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM | 03/06/2014 |
| K090043 | APEX BIOTECHNOLOGY CORP. | AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 | 04/09/2009 |
| K102037 | APEX BIOTECHNOLOGY CORP. | AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS | 08/13/2010 |
| K113208 | APEX BIOTECHNOLOGY CORP. | GAL-1A BLOOD GLUCOSE MONITORING SYSTEM | 01/26/2012 |
| K113547 | APEX BIOTECHNOLOGY CORP. | GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL | 03/28/2012 |
| K142689 | Apex BioTechnology Corp. | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | 08/06/2015 |
| K062799 | APEX BIOTECHNOLOGY CORP. | GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM | 02/06/2007 |
| K002624 | APEX BIOTECHNOLOGY CORP. | GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM | 01/22/2001 |
| K002621 | APEX BIOTECHNOLOGY CORP. | GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM | 01/22/2001 |
| K073648 | APEX BIOTECHNOLOGY CORP. | GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 | 04/10/2008 |
| K101204 | APEX BIOTECHNOLOGY CORP. | MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION | 08/31/2011 |
| K120448 | APEX BIOTECHNOLOGY CORP. | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL | 04/06/2012 |
| K011233 | APEX BIOTECHNOLOGY CORP. | MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 | 05/18/2001 |
| K124021 | ARKRAY FACTORY INC. | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | 06/30/2014 |
| K142336 | ARKRAY FACTORY INC. | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | 09/17/2014 |
| K073416 | ARKRAY Factory USA, Inc. | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | 06/13/2008 |
| K091102 | ARKRAY Factory USA, Inc. | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | 10/23/2009 |
| K092104 | ARKRAY Factory USA, Inc. | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | 11/24/2009 |
| K082417 | ARKRAY Factory USA, Inc. | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | 10/21/2008 |
| K041427 | ARKRAY, INC. | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS | 11/24/2004 |
| K972733 | AVL SCIENTIFIC CORP. | AVL OMNI ANALYZER | 09/09/1997 |
| K993837 | AVL SCIENTIFIC CORP. | AVL OPTI CRITICAL CARE ANALYZER | 12/16/1999 |
| K024062 | BAYER CORP. | ASCENSIA BREEZE BLOOD GLUCOSE METER | 03/03/2003 |
| K963500 | BAYER CORP. | GLUCOMETER DEX DIABETES CARE SYSTEM | 01/21/1997 |
| K964630 | BAYER CORP. | GLUCOMETER ELITE BLOOD GLUCOSE METER | 02/10/1997 |
| K991242 | BAYER CORP. | GLUCOMETER ELITE TEST STRIPS | 06/30/1999 |
| K984006 | BAYER CORP. | GLUCOMETER ELITE XL BLOOD GLUCOSE METER | 03/18/1999 |
| K990649 | BAYER CORP. | GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS | 07/09/1999 |
| K042015 | BAYER HEALTHCARE, DIAGNOSTICS DIVISION | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE | 09/29/2004 |
| K103842 | BECKMAN COULTER, INC. | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 | 04/27/2011 |
| K041478 | BECTON DICKINSON | BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR | 10/28/2004 |
| K022580 | BECTON DICKINSON & CO. | BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM | 10/09/2002 |
| K103116 | BESTGEN BIOTECH CORP. | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM | 03/13/2012 |
| K103230 | BESTGEN BIOTECH CORP. | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | 04/24/2012 |
| K033627 | BIOMEDIX, INC. | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | 05/21/2004 |
| K050182 | BIOMEDIX, INC. | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | 08/09/2005 |
| K944459 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM | 04/17/1996 |
| K102316 | BROADMASTER BIOTECH CORPORATION | GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM | 10/07/2011 |
| K061528 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | SELFCHECK GLUCO | 09/22/2006 |
| K021781 | CHAY MEDICAL, LLC. | EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS | 08/30/2002 |
| K013342 | CHAY MEDICAL, LLC. | EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. | 02/15/2002 |
| K943503 | CHEM-ELEC, INC. | CHEMCARD GLUCOSE TEST | 07/23/1996 |
| K980573 | CHRONIMED, INC. | SENSOREX BLOOD GLUCOSE MONITORING SYSTEM | 07/30/1998 |
| K963544 | CHRONIMED, INC. | SUPREME II METER | 02/20/1997 |
| K951457 | CLINICAL DIAGNOSTICS, INC. | GLUCOCHEK POCKETLAB | 02/22/1996 |
| K971653 | CLINICAL DIAGNOSTICS, INC. | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM | 01/02/1998 |
| K003257 | CYBERCARE TECHNOLOGIES, INC. | EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION | 12/22/2000 |
| K983344 | DADE BEHRING, INC. | DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL | 06/22/1999 |
| K033055 | DIAMOND DIAGNOSTICS, INC. | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | 01/30/2004 |
| K101741 | DIATRON GROUP | DIATRON PICTUS 400 | 01/25/2011 |
| K070704 | DREW SCIENTIFIC, INC. | TRILOGY ANALYZER | 07/13/2007 |
| K133584 | EOSHEALTH, INC. | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | 09/08/2014 |
| K090109 | EPOCAL, INC. | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | 06/24/2009 |
| K082121 | EPS BIO TECHNOLOGY CORP. | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 | 09/17/2008 |
| K061992 | EPS BIO TECHNOLOGY CORP. | EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 | 09/19/2006 |
| K111728 | EPS BIO TECHNOLOGY CORP. | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | 09/16/2011 |
| K043245 | EPS BIO TECHNOLOGY CORP. | EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM | 04/29/2005 |
| K062892 | EUMED BIOTECHNOLOGY CO., LTD. | EUKARE | 01/22/2007 |
| K981183 | EXIGENT DIAGNOSTICS, INC. | CARESIDE GLUCOSE | 05/07/1998 |
| K955107 | FIREHOUSE MEDICAL, INC. | SAFESTRIP | 08/16/1996 |
| K121706 | FORA CARE INC. | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM | 01/14/2013 |
| K971145 | GDS TECHNOLOGY, LLC. | GLUCOSITE TEST SYSTEM | 09/17/1997 |
| K040974 | GENCHEM, INC. | GLUCOSE OXIDASE, GLUCOSE | 12/27/2004 |
| K993128 | HEALTH HERO NETWORK, INC. | HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] | 11/23/1999 |
| K020935 | HEMOCUE, INC. | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 | 04/03/2002 |
| K960855 | HOME DIAGNOSTICS, INC. | PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL | 11/07/1996 |
| K992988 | HOME DIAGNOSTICS, INC. | PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM | 09/24/1999 |
| K080636 | HUBDIC CO., LTD | DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 | 02/13/2009 |
| K041881 | HYPOGUARD USA, INC. | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 | 03/25/2005 |
| K053079 | HYPOGUARD USA, INC. | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 | 03/28/2006 |
| K024347 | HYPOGUARD USA, INC. | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | 03/28/2003 |
| K020232 | HYPOGUARD USA, INC. | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | 02/12/2002 |
| K031388 | HYPOGUARD USA, INC. | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | 05/22/2003 |
| K103278 | i-SENS, Inc. | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION | 10/28/2011 |
| K121654 | i-SENS, Inc. | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION | 09/05/2012 |
| K120759 | i-SENS, Inc. | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION | 06/05/2012 |
| K001387 | I-STAT CORP. | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | 10/05/2000 |
| K001092 | INBIOS INTL., INC. | GENERIC BLOOD GLUCOSE TEST STRIP | 07/26/2000 |
| K052207 | INCLINE MEDICAL, LLC | ACCUREX GLUCOSE TEST STRIP | 03/09/2006 |
| K113670 | INFOPIA CO., LTD | ELEMENT BLOOD GLUCOSE MONITORING SYSTEM | 05/08/2012 |
| K051285 | INFOPIA CO., LTD | GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM | 08/02/2005 |
| K153692 | INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | 06/24/2016 |
| K223090 | Instrumentation Laboratory Co | GEM Premier ChemSTAT | 01/27/2023 |
| K052121 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 3000 | 10/21/2005 |
| K161818 | Instrumentation Laboratory Co. | GEM Premier 3000 | 09/14/2016 |
| K010520 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS | 05/07/2001 |
| K160402 | Instrumentation Laboratory Co. | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | 12/14/2016 |
| K183546 | Instrumentation Laboratory Co. | GEM Premier ChemSTAT | 02/16/2019 |
| K022158 | INSTRUMENTATION LABORATORY CO. | IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) | 09/10/2002 |
| K091975 | INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. | INTEGRATED LABORATORY AUTOMATION SOLUTION | 03/10/2010 |
| K011479 | INVERNESS MEDICAL INNOVATIONS, INC. | ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | 11/30/2001 |
| K955286 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) | 05/17/1996 |
| K984527 | LIFESCAN, INC. | IN TOUCH DIABETES MANAGEMENT SOFTWARE | 04/29/1999 |
| K031472 | LIFESCAN, INC. | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS | 08/05/2003 |
| K974451 | LIFESCAN, INC. | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | 01/26/1998 |
| K972473 | LIFESCAN, INC. | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK | 12/16/1997 |
| K021943 | LIFESCAN, INC. | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM | 06/28/2002 |
| K043197 | LIFESCAN, INC. | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | 05/20/2005 |
| K001441 | LIFESCAN, INC. | SATURN BLOOD GLUCOSE MONITORING TEST STRIP | 12/18/2000 |
| K984261 | LIFESCAN, INC. | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | 05/21/1999 |
| K970556 | LIFESCAN, INC. | SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM | 05/12/1997 |
| K023194 | LIFESCAN, INC. | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM | 10/24/2002 |
| K973140 | LXN CORP. | DUET GLUCOSE CONTROL MONITORING SYSTEM | 10/31/1997 |
| K990942 | LXN CORP. | DUET II GLUCOSE CONTROL MONITORING SYSTEM | 08/02/1999 |
| K991754 | LXN CORP. | GO GLUCOSE MONITORING SYSTEM | 09/08/1999 |
| K960034 | LXN CORP. | LXN BLOOD GLUCOSE TEST SYSTEM | 06/28/1996 |
| K002688 | LXN CORP. | PERSONAL GLUCOSE CONTROL CHARTING SYSTEM | 02/01/2001 |
| K070057 | MEDICA CORP. | EASYRA CLINICAL CHEMISTRY ANALYZER | 08/30/2007 |
| K100187 | MEDICA CORP. | EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT | 05/05/2010 |
| K961337 | MEDISENSE, INC. | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM | 06/21/1996 |
| K963676 | MEDISENSE, INC. | PRECISION G BLOOD GLUCOSE TESTING SYSTEM | 02/20/1997 |
| K982303 | MEDISENSE, INC. | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST | 12/08/1998 |
| K962295 | MEDISENSE, INC. | PRECISION QID BLOOD GLUCOSE TEST STRIP | 07/26/1996 |
| K971812 | MEDISENSE, INC. | PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP | 08/08/1997 |
| K983504 | MEDISENSE, INC. | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST | 07/09/1999 |
| K063821 | NOVA BIOMEDICAL CORP. | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | 01/24/2007 |
| K060345 | NOVA BIOMEDICAL CORP. | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | 04/28/2006 |
| K070960 | NOVA BIOMEDICAL CORP. | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | 07/11/2007 |
| K203549 | Nova Biomedical Corporation | Nova Primary Glucose Analyzer System | 10/18/2022 |
| K180340 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 09/26/2018 |
| K200349 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 03/13/2020 |
| K163433 | Ortho Clinical Diagnostics | VITROS Chemistry Products GLU Slides | 09/18/2017 |
| K190520 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products GLU-Ca Slides | 04/03/2019 |
| K113636 | PHILOSYS CO. LTD. | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) | 03/08/2013 |
| K970781 | POINTE SCIENTIFIC, INC. | LIQUID GLUCOSE (OXIDASE) REAGENT SET | 04/21/1997 |
| K013068 | POLYMER TECHNOLOGY SYSTEMS, INC. | BIOSCANNER 2000 | 11/20/2001 |
| K142302 | Polymer Technology Systems, Inc. | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis | 10/02/2014 |
| K151530 | POLYMER TECHNOLOGY SYSTEMS, INC. | CardioChek Plus Test System | 07/07/2015 |
| K972669 | POLYMER TECHNOLOGY SYSTEMS, INC. | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON | 01/22/1998 |
| K162282 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics | CardioChek Plus Test System, CardioChek Home Test System | 12/22/2016 |
| K182781 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics | PTS Professional Chemistry Kit | 12/21/2018 |
| K003346 | RANDOX LABORATORIES, LTD. | RANDOX GLUCOSE (GOD/PAP) | 03/15/2001 |
| K024014 | RANDOX LABORATORIES, LTD. | RANDOX RX DAYTONA | 12/04/2003 |
| K000365 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ADVANTAGE METER | 02/23/2000 |
| K001907 | ROCHE DIAGNOSTICS CORP. | CAMIT DIABETES MANAGEMENT SOFTWARE | 09/05/2000 |
| K014139 | ROCHE DIAGNOSTICS CORP. | DIABETES ASSISTANT SOFTWARE | 03/21/2002 |
| K961985 | SELFCARE, INC. | ELECT BLOOD GLUCOSE MONITORIG SYSTEM | 09/05/1996 |
| K970707 | SELFCARE, INC. | ELECT II BLOOD GLUCOSE MONITORING SYSTEM | 06/20/1997 |
| K991480 | SELFCARE, INC. | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP | 09/17/1999 |
| K000583 | SELFCARE, INC. | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 03/17/2000 |
| K990939 | SELFCARE, INC. | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 04/20/1999 |
| K993632 | SELFCARE, INC. | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 11/12/1999 |
| K001427 | SELFCARE, INC. | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 06/02/2000 |
| K002134 | SELFCARE, INC. | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | 08/07/2000 |
| K960053 | SELFCARE, INC. | SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM | 06/28/1996 |
| K151639 | SENDX MEDICAL INC | ABL80 FLEX and ABL80 FLEX CO-OX | 12/07/2015 |
| K100525 | SEPPIM S.A.S. | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 | 12/15/2010 |
| K963535 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS GLUCOSE REAGENT | 01/17/1997 |
| K120921 | SIMPLE DIAGNOSTICS, INC. | CLEVER CHOICE | 08/21/2012 |
| K101947 | SPHERE MEDICAL LTD. | IVD-GE02 | 03/16/2011 |
| K081609 | TaiDoc Technology Corporation | CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 | 07/02/2008 |
| K093506 | TaiDoc Technology Corporation | CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 | 04/01/2010 |
| K093941 | TaiDoc Technology Corporation | CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 | 03/26/2010 |
| K091814 | TaiDoc Technology Corporation | FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE | 11/20/2009 |
| K100405 | TaiDoc Technology Corporation | FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM | 07/09/2010 |
| K081714 | TaiDoc Technology Corporation | FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | 07/25/2008 |
| K083664 | TaiDoc Technology Corporation | FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 | 01/09/2009 |
| K082482 | TaiDoc Technology Corporation | FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 | 01/30/2009 |
| K100406 | TaiDoc Technology Corporation | FORA V20 BLOOD GLUCOSE MONITORING SYSTEM | 05/11/2010 |
| K083570 | TaiDoc Technology Corporation | U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM | 03/11/2009 |
| K061431 | US DIAGNOSTICS, INC. | EASYGLUCO, MODEL IGM-0002 G2 | 01/12/2007 |
| K011953 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA | 12/21/2001 |
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