| XR-Series (XR-10, XR-20) Automated Hematology Analyzers (K253212) | Sysmex America, Inc. | 2026-05-27 |
| Athelas Home (K243348) | Athelas, Inc. | 2026-02-06 |
| Tru Hematology Test (K251249) | Truvian Sciences, Inc. | 2026-01-16 |
| Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943) | Sysmex America, Inc. | 2025-06-25 |
| Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371) | Sysmex America, Inc. | 2025-06-25 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Cito CBC System (K240402) | Cytochip, Inc. | 2025-02-03 |
| UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (K240252) | Beckman Coulter, Inc. | 2024-07-05 |
| Yumizen H2500 (K232946) | HORIBA ABX SAS | 2024-05-21 |
| HemoScreen Hematology Analyzer (K240636) | Pixcell Medical Technologies | 2024-05-02 |
| Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (K230887) | Sysmex America, Inc. | 2023-12-21 |
| QScout Lab; QScout RLD (K230878) | Ad Astra Diagnostics, Inc. | 2023-11-14 |
| HemoScreen Hematology Analyzer (K222148) | Pixcell Medical Technologies, Ltd. | 2023-08-16 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |
| Sysmex XW-100 Automated Hematology Analyzer (K210346) | Sysmex America, Inc. | 2022-11-08 |
| Sight OLO (K211840) | S.D. Sight Diagnostics , Ltd. | 2022-05-09 |
| Athelas Home (K200828) | Athelas, Inc. | 2022-03-22 |
| Unicel DxH 800 Coulter Cellular Analysis System (K193124) | Beckman Coulter | 2020-04-16 |
| Sight OLO (K190898) | Sight Diagnostics , Ltd. | 2019-11-01 |
| Cytomics FC 500 Series (MPL or MCL) Flow Cytometer (K182886) | Beckman Coulter | 2019-09-06 |
| CELL-DYN Emerald 22 AL System (K190294) | Abbott Laboratories | 2019-03-15 |
| DxH 520 Hematology Instrument (K181475) | Beckman Coulter | 2019-03-01 |
| Sysmex XN-L Automated Hematology Analyzer (K182389) | Sysmex America, Inc. | 2019-01-25 |
| Athelas One (K181288) | Athelas, Inc. | 2018-11-05 |
| HemoScreen Hematology Analyzer (K180020) | Pixcell Medical Technologies, Ltd. | 2018-10-29 |
| cobas m 511 integrated hematology analyzer (K171655) | Roche Diagnostics Hematology, Inc. | 2018-03-02 |
| XW-100 Automated Hematology Analyzer for CLIA Waived Use (K172604) | Sysmex America, Inc. | 2017-11-06 |
| ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (K170353) | HORIBA ABX SAS | 2017-11-01 |
| ADVIA 2120i, ADVIA 2120 (K162977) | Siemens Healthcare Diagnostics | 2017-08-11 |
| Dextramer CMV Kit (K153538) | Immudex Aps | 2017-03-02 |
| Sysmex XN-L Automated Hematology Analyzer (K160538) | Sysmex America, Inc. | 2016-12-22 |
| UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System (K162414) | Beckman Coulter, Inc. | 2016-11-29 |
| BC-5390 Auto Hematology Analyzer (K160429) | Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-01 |
| PENTRA XLR (K151133) | HORIBA ABX SAS | 2015-12-09 |
| XW-100 Automated Hematology Analyzer, XW QC CHECK (K143577) | Sysmex America, Inc. | 2015-10-12 |
| BC-3600 Auto Hematology Analyzer (K143348) | Mindray Bio-Medical Electronics Co., Ltd. | 2015-08-21 |
| ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) (K141161) | HORIBA ABX SAS | 2014-12-20 |
| SYSMEX XN SERIES (K141681) | Sysmex America, Inc. | 2014-12-05 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (K140911) | Beckman Coulter, Inc. | 2014-09-05 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K120771) | Beckman Coulter, Inc. | 2013-03-22 |
| SYSMEX XN-SERIES (K112605) | Sysmex America, Inc. | 2012-10-19 |
| ABACUS 3CP (K111534) | Diatron U.S., Inc. | 2012-08-02 |
| ABACUS 5 (K112755) | Diatron U.S., Inc. | 2012-03-27 |
| CELL-DYN EMERALD 22 SYSTEM (K110381) | Abbott Laboratories | 2011-12-22 |
| ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I (K102644) | Siemens Healthcare Diagnostics | 2011-11-23 |
| BD FACS SAMPLE PREP ASSISTANT III (SPA III) (K102064) | Becton, Dickinson & CO | 2011-03-07 |
| DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 (K100489) | Beckman Coulter Cellular | 2010-10-26 |
| ADVIA 2120/2120I BODY FLUIDS (K090346) | Siemens Healthcare Diagnostics | 2010-07-28 |
| BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C (K093394) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-08 |
| SYSMEX MODEL XT-4000I (K091313) | Sysmex America, Inc. | 2010-03-30 |
| THERMO SCIENTIFIC CYTO-CAL COUNT TUBES (K090810) | Microgenics Corp. | 2009-09-18 |
| BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 (K090967) | Bd Biosciences | 2009-07-31 |
| CHEMPAQ XBC ANALYZER (K090013) | Chempaq A/S | 2009-04-21 |
| TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 (K082091) | Reametrix, Inc. | 2009-04-15 |
| CELL-DYN EMERALD SYSTEM (K081495) | Abbott Laboratories | 2009-02-04 |
| MEDONIC M SERIES (K083420) | Boule Medical AB | 2009-02-03 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) | Beckman Coulter, Inc. | 2008-12-19 |
| SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER (K081890) | Sysmex America, Inc. | 2008-10-10 |
| SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER (K081610) | Sysmex America, Inc. | 2008-08-29 |
| FLOWCARE TLG REAGENT (K081526) | Beckman Coulter, Inc. | 2008-08-14 |
| BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (K081213) | Bd Biosciences | 2008-08-14 |
| POINTCARE NOW SYSTEM (K072869) | Pointcare Technologies, Inc. | 2008-01-14 |
| D3 HEMATOLOGY ANALYZER, MODEL D3 (K071562) | Drew Scientific, Inc. | 2007-12-11 |
| SYSMEX XE-5000 (K071967) | Sysmex America, Inc. | 2007-11-20 |
| CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 (K071681) | Beckman Coulter, Inc. | 2007-10-04 |
| BC-3200 AUTO HEMATOLOGY ANALYZER (K063407) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-06-11 |
| BD TRITEST CD3/CD4/CD45, MODEL 340383 (K071143) | Bd Biosciences | 2007-06-06 |
| BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (K071141) | Bd Biosciences | 2007-06-06 |
| COULTER LH 780 HEMATOLOGY ANALYZER (K061616) | Beckman Coulter, Inc. | 2006-10-04 |
| BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 (K062087) | Bd Biosciences | 2006-09-14 |
| CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES (K060423) | Dakocytomation California, Inc. | 2006-08-15 |
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K061574) | Beckman Coulter, Inc. | 2006-07-21 |
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES (K061150) | Sysmex America, Inc. | 2006-07-06 |
| BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 (K060375) | Bd Biosciences | 2006-06-06 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES (K060656) | Sysmex America, Inc. | 2006-05-10 |
| GUAVA EZCD4 SYSTEM (K053497) | Guava Technologies, Inc. | 2006-04-14 |
| ABX MICROS CRP 200, OPTION IM (K053308) | Horiba Abx | 2005-12-29 |
| CHEMPAQ XBC ANALYZER (K050758) | Chempaq A/S | 2005-12-22 |
| MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER (K052905) | Beckman Coulter, Inc. | 2005-11-18 |
| SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER (K051459) | Sysmex America, Inc. | 2005-09-23 |
| MS 4/5 HEMATOLOGY ANALYZER (K050421) | Melet Schloesing Laboratories USA | 2005-08-31 |
| IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K051199) | Sysmex America, Inc. | 2005-08-08 |
| ITAG MHC TETRAMER CMV ASSAY (K051122) | Beckman Coulter, Inc. | 2005-08-01 |
| MS 9/5 HEMATOLOGY ANALYZER (K050436) | Melet Schloesing Laboratories USA | 2005-07-27 |
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |
| RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K050589) | Sysmex America, Inc. | 2005-05-04 |
| ABX PENTRA DX 120: OPTION SPS EVOLUTION (K050719) | Horiba Abx | 2005-04-26 |
| COULTER LH 750 HEMATOLOGY ANALYZER (K050057) | Beckman Coulter, Inc. | 2005-02-10 |
| FLOWCARE PLG CD4 REAGENT (K043215) | Beckman Coulter, Inc. | 2005-01-19 |
| FLOWCARE SYSTEM (K041882) | Pointcare Technologies, Inc. | 2004-11-23 |
| MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER (K042724) | Beckman Coulter, Inc. | 2004-10-29 |
| COULTER A T 5DIFF CAP PIERCE (CP) (K042173) | Beckman Coulter, Inc. | 2004-10-12 |
| BD FACSCANTO WITH BD FACSANTO SOFTWARE (K041074) | Bd Biosciences | 2004-09-17 |
| BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K042251) | Bayer Healthcare, LLC | 2004-09-17 |
| BD FACSCANTO SYSTEM (K040725) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| BD FACS 7-COLOR SETUP BEADS (K040026) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) (K040073) | Sysmex America, Inc. | 2004-03-18 |
| MEDONIC CA620/530 HEMATOLOGY ANALYZER (K032214) | Boule Medical AB | 2004-01-29 |
| IMMUNICON CELLTRACKS ANALYZER (K030263) | Immunicon Corp. | 2003-11-24 |