FDA 510(k) Applications for Medical Device Product Code "GKZ"
(Counter, Differential Cell)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961439 | ABBOTT DIAGNOSTICS | ABBOTT CELL-DYN 4000 SYSTEM | 10/18/1996 |
| K980614 | ABBOTT LABORATORIES | ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS | 04/24/1998 |
| K972354 | ABBOTT LABORATORIES | ABBOTT CELL-DYN 3200 SYSTEM | 09/16/1997 |
| K971152 | ABBOTT LABORATORIES | ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) | 08/12/1997 |
| K981342 | ABBOTT LABORATORIES | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY | 06/29/1998 |
| K220031 | Abbott Laboratories | Alinity h-series System | 08/04/2023 |
| K955673 | ABBOTT LABORATORIES | CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) | 05/20/1996 |
| K955715 | ABBOTT LABORATORIES | CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) | 10/08/1996 |
| K991142 | ABBOTT LABORATORIES | CELL-DYN 1200 SYSTEM | 06/23/1999 |
| K030513 | ABBOTT LABORATORIES | CELL-DYN 1800 SYSTEM | 05/12/2003 |
| K012934 | ABBOTT LABORATORIES | CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE | 09/28/2001 |
| K991605 | ABBOTT LABORATORIES | CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION | 07/09/1999 |
| K010953 | ABBOTT LABORATORIES | CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY | 06/06/2001 |
| K190294 | Abbott Laboratories | CELL-DYN Emerald 22 AL System | 03/15/2019 |
| K110381 | ABBOTT LABORATORIES | CELL-DYN EMERALD 22 SYSTEM | 12/22/2011 |
| K081495 | ABBOTT LABORATORIES | CELL-DYN EMERALD SYSTEM | 02/04/2009 |
| K061667 | ABBOTT LABORATORIES | CELL-DYN RUBY SYSTEM | 07/10/2006 |
| K051215 | ABBOTT LABORATORIES | CELL-DYN SAPPHIRE SYSTEM | 07/21/2005 |
| K992444 | ABBOTT LABORATORIES | MODIFICATION OF: CELL-DYN 1200 SYSTEM | 09/24/1999 |
| K002646 | ABX DIAGNOSTICS | ABX MICROS CRP | 10/26/2000 |
| K991839 | ABX DIAGNOSTICS | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER | 08/11/1999 |
| K992511 | ABX DIAGNOSTICS | ABX PENTRA 60 HEMATOLOGY ANALYZER | 10/15/1999 |
| K003677 | ABX DIAGNOSTICS | ABX PENTRA 60C+ HEMATOLOGY ANALYZER | 12/26/2000 |
| K030799 | ABX DIAGNOSTICS | MICROS 60 | 04/08/2003 |
| K030144 | ABX DIAGNOSTICS | MODIFICATION TO PENTRA 60 AND PENTRA 60C+ | 01/31/2003 |
| K022200 | ABX DIAGNOSTICS | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 | 07/29/2002 |
| K024002 | ABX DIAGNOSTICS | PENTRA 80 | 01/03/2003 |
| K990311 | ABX DIAGNOSTICS | VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER | 03/31/1999 |
| K962633 | ABX, INC. | VEGA HEMATOLOGY ANALYZER | 11/04/1996 |
| K200828 | Athelas Inc. | Athelas Home | 03/22/2022 |
| K181288 | Athelas Inc. | Athelas One | 11/05/2018 |
| K003796 | BAYER CORP. | ADVIA 120 HEMATOLOGY | 02/05/2001 |
| K982802 | BAYER CORP. | BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 09/22/1998 |
| K954594 | BAYER CORP. | RETICULOCYTE METHOD, RBC INDICES | 08/23/1996 |
| K022668 | BAYER DIAGNOSTICS CORP. | ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD | 10/15/2002 |
| K012904 | BAYER DIAGNOSTICS CORP. | ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION | 09/21/2001 |
| K032524 | BAYER HEALTHCARE, LLC | ADVIA 60 HEMATOLOGY ANALYZER | 09/08/2003 |
| K042251 | BAYER HEALTHCARE, LLC | BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | 09/17/2004 |
| K992849 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM | 09/23/1999 |
| K062087 | BD Biosciences | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 | 09/14/2006 |
| K041074 | BD Biosciences | BD FACSCANTO WITH BD FACSANTO SOFTWARE | 09/17/2004 |
| K081213 | BD Biosciences | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 | 08/14/2008 |
| K060375 | BD Biosciences | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 | 06/06/2006 |
| K090967 | BD Biosciences | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 | 07/31/2009 |
| K071141 | BD Biosciences | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 | 06/06/2007 |
| K071143 | BD Biosciences | BD TRITEST CD3/CD4/CD45, MODEL 340383 | 06/06/2007 |
| K000897 | BD Biosciences | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE | 05/05/2000 |
| K000611 | BD Biosciences | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER | 05/18/2000 |
| K182886 | Beckman Coulter | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | 09/06/2019 |
| K181475 | Beckman Coulter | DxH 520 Hematology Instrument | 03/01/2019 |
| K193124 | Beckman Coulter | Unicel DxH 800 Coulter Cellular Analysis System | 04/16/2020 |
| K100489 | BECKMAN COULTER CELLULAR | DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 | 10/26/2010 |
| K042173 | BECKMAN COULTER, INC. | COULTER A T 5DIFF CAP PIERCE (CP) | 10/12/2004 |
| K032013 | BECKMAN COULTER, INC. | COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER | 07/24/2003 |
| K030291 | BECKMAN COULTER, INC. | COULTER ACT 5DIFF AUTOLOADER (AL) | 04/17/2003 |
| K010765 | BECKMAN COULTER, INC. | COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 | 04/13/2001 |
| K032000 | BECKMAN COULTER, INC. | COULTER LH 500 HEMATOLOGY ANALYZER | 08/13/2003 |
| K030606 | BECKMAN COULTER, INC. | COULTER LH 750 BODY FLUIDS APPLICATION | 04/21/2003 |
| K032342 | BECKMAN COULTER, INC. | COULTER LH 750 HEMATOLOGY ANALYZER | 09/26/2003 |
| K050057 | BECKMAN COULTER, INC. | COULTER LH 750 HEMATOLOGY ANALYZER | 02/10/2005 |
| K011342 | BECKMAN COULTER, INC. | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 | 07/09/2001 |
| K061574 | BECKMAN COULTER, INC. | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 | 07/21/2006 |
| K061616 | BECKMAN COULTER, INC. | COULTER LH 780 HEMATOLOGY ANALYZER | 10/04/2006 |
| K030408 | BECKMAN COULTER, INC. | CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A | 03/04/2003 |
| K071681 | BECKMAN COULTER, INC. | CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 | 10/04/2007 |
| K043215 | BECKMAN COULTER, INC. | FLOWCARE PLG CD4 REAGENT | 01/19/2005 |
| K081526 | BECKMAN COULTER, INC. | FLOWCARE TLG REAGENT | 08/14/2008 |
| K051122 | BECKMAN COULTER, INC. | ITAG MHC TETRAMER CMV ASSAY | 08/01/2005 |
| K042724 | BECKMAN COULTER, INC. | MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER | 10/29/2004 |
| K052905 | BECKMAN COULTER, INC. | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER | 11/18/2005 |
| K022161 | BECKMAN COULTER, INC. | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 | 07/29/2002 |
| K030828 | BECKMAN COULTER, INC. | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) | 05/21/2003 |
| K081930 | BECKMAN COULTER, INC. | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | 12/19/2008 |
| K120771 | BECKMAN COULTER, INC. | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | 03/22/2013 |
| K140911 | BECKMAN COULTER, INC. | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM | 09/05/2014 |
| K162414 | BECKMAN COULTER, INC. | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System | 11/29/2016 |
| K102064 | BECTON DICKINSON & CO. | BD FACS SAMPLE PREP ASSISTANT III (SPA III) | 03/07/2011 |
| K955504 | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS | QBC ACCUREAD SYSTEM | 02/05/1996 |
| K960827 | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS | QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) | 05/17/1996 |
| K040026 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | BD FACS 7-COLOR SETUP BEADS | 09/10/2004 |
| K040725 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | BD FACSCANTO SYSTEM | 09/10/2004 |
| K973483 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET | 02/17/1998 |
| K963963 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS | 12/12/1996 |
| K980858 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION | 05/22/1998 |
| K974360 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | MULTITEST CD3/CD8/CD45/CD4 | 03/11/1998 |
| K971205 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES | 12/01/1997 |
| K970742 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES | 10/22/1997 |
| K971110 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | 11/25/1997 |
| K950342 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP | 02/20/1996 |
| K946055 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP | 02/20/1996 |
| K965053 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES | 11/21/1997 |
| K970326 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | 11/21/1997 |
| K970836 | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS | 08/26/1997 |
| K961623 | BECTON DICKINSON MONOCLONAL CENTER | FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS | 06/07/1996 |
| K960072 | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. | SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX | 03/06/1997 |
| K032214 | BOULE MEDICAL AB | MEDONIC CA620/530 HEMATOLOGY ANALYZER | 01/29/2004 |
| K083420 | BOULE MEDICAL AB | MEDONIC M SERIES | 02/03/2009 |
| K965232 | CALTAG LABORATORIES, INC. | CALTAG CAL-LYSE | 05/14/1997 |
| K963954 | CALTAG LABORATORIES, INC. | CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY | 11/25/1996 |
| K964856 | CALTAG LABORATORIES, INC. | CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | 01/17/1997 |
| K981568 | CDC TECHNOLOGIES, INC. | MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 | 08/21/1998 |
| K983562 | CDC TECHNOLOGIES, INC. | MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 | 11/03/1998 |
| K942525 | CEA AMERICA CORP. | MEDICOUNT DEKA HEMATOLOGY ANALYZER | 06/05/1996 |
| K050758 | CHEMPAQ A/S | CHEMPAQ XBC ANALYZER | 12/22/2005 |
| K090013 | CHEMPAQ A/S | CHEMPAQ XBC ANALYZER | 04/21/2009 |
| K990352 | COULTER CORP. | COULTER AC T DIFF 2 ANALYZER | 04/01/1999 |
| K973634 | COULTER CORP. | COULTER AC.T DIFF ANALYZER | 10/29/1997 |
| K964988 | COULTER CORP. | COULTER AC.T SERIES ANALYZER | 03/06/1997 |
| K993356 | COULTER CORP. | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | 04/20/2000 |
| K961278 | COULTER CORP. | COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS | 07/22/1996 |
| K982172 | COULTER CORP. | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | 09/24/1998 |
| K982167 | COULTER CORP. | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | 11/09/1998 |
| K962768 | COULTER CORP. | CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL | 01/06/1997 |
| K982166 | COULTER CORP. | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | 11/05/1998 |
| K962305 | COULTER CORP. | CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL | 01/06/1997 |
| K964618 | COULTER CORP. | CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 | 12/23/1996 |
| K954688 | COULTER CORP. | FLOW-COUNT COULTER FLUOROSPHERES | 02/29/1996 |
| K990327 | COULTER CORP. | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS | 04/26/1999 |
| K963263 | COULTER CORP. | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 | 01/22/1997 |
| K990172 | COULTER CORP. | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA | 04/13/1999 |
| K980635 | DAKO CORP. | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 | 07/22/1998 |
| K991402 | DAKO CORP. | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 | 06/21/1999 |
| K945212 | DAKO CORP. | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ | 01/26/1996 |
| K961435 | DAKO CORP. | MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE | 06/14/1996 |
| K955909 | DAKO CORP. | MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE | 03/28/1996 |
| K961701 | DAKO CORP. | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE | 07/16/1996 |
| K960531 | DAKO CORP. | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE | 06/14/1996 |
| K960887 | DAKO CORP. | MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE | 05/17/1996 |
| K964974 | DAKO CORP. | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE | 06/24/1997 |
| K991454 | DAKO CORP. | MOUSE IGG1 NEGATIVE CONTROLS | 06/21/1999 |
| K060423 | DAKOCYTOMATION CALIFORNIA, INC. | CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES | 08/15/2006 |
| K111534 | DIATRON US INC | ABACUS 3CP | 08/02/2012 |
| K112755 | DIATRON US INC | ABACUS 5 | 03/27/2012 |
| K071562 | DREW SCIENTIFIC, INC. | D3 HEMATOLOGY ANALYZER, MODEL D3 | 12/11/2007 |
| K053497 | GUAVA TECHNOLOGIES, INC. | GUAVA EZCD4 SYSTEM | 04/14/2006 |
| K053308 | HORIBA ABX | ABX MICROS CRP 200, OPTION IM | 12/29/2005 |
| K050719 | HORIBA ABX | ABX PENTRA DX 120: OPTION SPS EVOLUTION | 04/26/2005 |
| K141161 | HORIBA ABX SAS | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) | 12/20/2014 |
| K170353 | HORIBA ABX SAS | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | 11/01/2017 |
| K151133 | HORIBA ABX SAS | PENTRA XLR | 12/09/2015 |
| K153538 | Immudex Aps | Dextramer CMV Kit | 03/02/2017 |
| K030263 | IMMUNICON CORP. | IMMUNICON CELLTRACKS ANALYZER | 11/24/2003 |
| K953116 | INTL. REMOTE IMAGING SYSTEMS | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER | 05/13/1996 |
| K022528 | IQ CORP. | IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ | 09/11/2002 |
| K050421 | MELET SCHLOESING LABORATORIES USA | MS 4/5 HEMATOLOGY ANALYZER | 08/31/2005 |
| K050436 | MELET SCHLOESING LABORATORIES USA | MS 9/5 HEMATOLOGY ANALYZER | 07/27/2005 |
| K090810 | MICROGENICS CORP. | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES | 09/18/2009 |
| K143348 | MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BC-3600 Auto Hematology Analyzer | 08/21/2015 |
| K160429 | MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BC-5390 Auto Hematology Analyzer | 09/01/2016 |
| K991539 | MWI, INC. | EXCELL 22 | 07/01/1999 |
| K935720 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | 05/09/1996 |
| K954570 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | 04/30/1996 |
| K951100 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | 05/13/1996 |
| K950568 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | 05/13/1996 |
| K950625 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | 05/13/1996 |
| K951632 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | 03/06/1997 |
| K950482 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | 05/10/1996 |
| K964754 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | 01/22/1997 |
| K951459 | ORTHO DIAGNOSTIC SYSTEMS, INC. | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | 07/14/1997 |
| K180020 | PixCell Medical Technologies, Ltd. | HemoScreen Hematology Analyzer | 10/29/2018 |
| K222148 | PixCell Medical Technologies, Ltd. | HemoScreen Hematology Analyzer | 08/16/2023 |
| K041882 | POINTCARE TECHNOLOGIES INC. | FLOWCARE SYSTEM | 11/23/2004 |
| K072869 | POINTCARE TECHNOLOGIES INC. | POINTCARE NOW SYSTEM | 01/14/2008 |
| K961610 | R & D SYSTEMS, INC. | R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) | 07/01/1996 |
| K982231 | R & D SYSTEMS, INC. | STATUSFLOW | 07/20/1998 |
| K082091 | REAMETRIX INC. | TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 | 04/15/2009 |
| K171655 | Roche Diagnostics Hematology, Inc. | cobas m 511 integrated hematology analyzer | 03/02/2018 |
| K211840 | S.D. Sight Diagnostics Ltd. | Sight OLO | 05/09/2022 |
| K960427 | SEQUOIA TURNER CORP. | ABBOTT CELL-DYN 3500R SYSTEM | 05/02/1996 |
| K953598 | SERONO DIAGNOSTICS, INC. | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | 03/11/1996 |
| K063407 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BC-3200 AUTO HEMATOLOGY ANALYZER | 06/11/2007 |
| K093394 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C | 04/08/2010 |
| K102644 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I | 11/23/2011 |
| K090346 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA 2120/2120I BODY FLUIDS | 07/28/2010 |
| K162977 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA 2120i, ADVIA 2120 | 08/11/2017 |
| K190898 | Sight Diagnostics Ltd. | Sight OLO | 11/01/2019 |
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| K050589 | SYSMEX AMERICA, INC. | RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER | 05/04/2005 |
| K060656 | SYSMEX AMERICA, INC. | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES | 05/10/2006 |
| K040073 | SYSMEX AMERICA, INC. | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) | 03/18/2004 |
| K061150 | SYSMEX AMERICA, INC. | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES | 07/06/2006 |
| K051459 | SYSMEX AMERICA, INC. | SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER | 09/23/2005 |
| K081610 | SYSMEX AMERICA, INC. | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER | 08/29/2008 |
| K091313 | SYSMEX AMERICA, INC. | SYSMEX MODEL XT-4000I | 03/30/2010 |
| K071967 | SYSMEX AMERICA, INC. | SYSMEX XE-5000 | 11/20/2007 |
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