FDA Product Code
FDA Product Code GKZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5220
510(k) Clearances — 381 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260781 | Yumizen H550 | HORIBA ABX SAS | 2026-09-14 | Traditional | PDF ↗ |
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | 2026-05-27 | Traditional | PDF ↗ |
| K243348 | Athelas Home | Athelas, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K243283 | Alinity h-series System | Abbott Laboratories | 2025-02-20 | Traditional | PDF ↗ |
| K240402 | Cito CBC System | Cytochip, Inc. | 2025-02-03 | Dual Track | PDF ↗ |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2024-07-05 | Traditional | PDF ↗ |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | 2024-05-21 | Traditional | PDF ↗ |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | 2024-05-02 | Abbreviated | PDF ↗ |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | 2023-12-21 | Traditional | PDF ↗ |
| K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | 2023-11-14 | Traditional | PDF ↗ |
| K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2023-08-16 | Traditional | PDF ↗ |
| K220031 | Alinity h-series System | Abbott Laboratories | 2023-08-04 | Traditional | PDF ↗ |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022-11-08 | Dual Track | PDF ↗ |
| K211840 | Sight OLO | S.D. Sight Diagnostics , Ltd. | 2022-05-09 | Traditional | PDF ↗ |
| K200828 | Athelas Home | Athelas, Inc. | 2022-03-22 | Traditional | PDF ↗ |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020-04-16 | Traditional | PDF ↗ |
| K190898 | Sight OLO | Sight Diagnostics , Ltd. | 2019-11-01 | Traditional | PDF ↗ |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | 2019-09-06 | Traditional | PDF ↗ |
| K190294 | CELL-DYN Emerald 22 AL System | Abbott Laboratories | 2019-03-15 | Special | PDF ↗ |
| K181475 | DxH 520 Hematology Instrument | Beckman Coulter | 2019-03-01 | Traditional | PDF ↗ |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | 2019-01-25 | Traditional | PDF ↗ |
| K181288 | Athelas One | Athelas, Inc. | 2018-11-05 | Traditional | PDF ↗ |
| K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2018-10-29 | Traditional | PDF ↗ |
| K171655 | cobas m 511 integrated hematology analyzer | Roche Diagnostics Hematology, Inc. | 2018-03-02 | Traditional | PDF ↗ |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | 2017-11-06 | Dual Track | PDF ↗ |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | HORIBA ABX SAS | 2017-11-01 | Traditional | PDF ↗ |
| K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | 2017-08-11 | Traditional | PDF ↗ |
| K153538 | Dextramer CMV Kit | Immudex Aps | 2017-03-02 | Traditional | PDF ↗ |
| K160538 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2016-11-29 | Special | PDF ↗ |
| K160429 | BC-5390 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-01 | Traditional | PDF ↗ |
| K151133 | PENTRA XLR | HORIBA ABX SAS | 2015-12-09 | Traditional | PDF ↗ |
| K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | Sysmex America, Inc. | 2015-10-12 | Traditional | PDF ↗ |
| K143348 | BC-3600 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2015-08-21 | Traditional | PDF ↗ |
| K141161 | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) | HORIBA ABX SAS | 2014-12-20 | Traditional | PDF ↗ |
| K141681 | SYSMEX XN SERIES | Sysmex America, Inc. | 2014-12-05 | Traditional | PDF ↗ |
| K140911 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM | Beckman Coulter, Inc. | 2014-09-05 | Abbreviated | PDF ↗ |
| K120771 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | Beckman Coulter, Inc. | 2013-03-22 | Abbreviated | PDF ↗ |
| K112605 | SYSMEX XN-SERIES | Sysmex America, Inc. | 2012-10-19 | Traditional | PDF ↗ |
| K111534 | ABACUS 3CP | Diatron U.S., Inc. | 2012-08-02 | Traditional | PDF ↗ |
| K112755 | ABACUS 5 | Diatron U.S., Inc. | 2012-03-27 | Traditional | PDF ↗ |
| K110381 | CELL-DYN EMERALD 22 SYSTEM | Abbott Laboratories | 2011-12-22 | Traditional | PDF ↗ |
| K102644 | ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I | Siemens Healthcare Diagnostics | 2011-11-23 | Traditional | PDF ↗ |
| K102064 | BD FACS SAMPLE PREP ASSISTANT III (SPA III) | Becton, Dickinson & CO | 2011-03-07 | Traditional | PDF ↗ |
| K100489 | DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 | Beckman Coulter Cellular | 2010-10-26 | Traditional | PDF ↗ |
| K090346 | ADVIA 2120/2120I BODY FLUIDS | Siemens Healthcare Diagnostics | 2010-07-28 | Traditional | PDF ↗ |
| K093394 | BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-08 | Traditional | PDF ↗ |
| K091313 | SYSMEX MODEL XT-4000I | Sysmex America, Inc. | 2010-03-30 | Traditional | PDF ↗ |
| K090810 | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES | Microgenics Corp. | 2009-09-18 | Traditional | PDF ↗ |
| K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 | Bd Biosciences | 2009-07-31 | Traditional | PDF ↗ |
| K090013 | CHEMPAQ XBC ANALYZER | Chempaq A/S | 2009-04-21 | Special | PDF ↗ |
| K082091 | TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 | Reametrix, Inc. | 2009-04-15 | Traditional | PDF ↗ |
| K081495 | CELL-DYN EMERALD SYSTEM | Abbott Laboratories | 2009-02-04 | Traditional | PDF ↗ |
| K083420 | MEDONIC M SERIES | Boule Medical AB | 2009-02-03 | Special | PDF ↗ |
| K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | Beckman Coulter, Inc. | 2008-12-19 | Abbreviated | PDF ↗ |
| K081890 | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER | Sysmex America, Inc. | 2008-10-10 | Traditional | PDF ↗ |
| K081610 | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER | Sysmex America, Inc. | 2008-08-29 | Traditional | PDF ↗ |
| K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 | Bd Biosciences | 2008-08-14 | Traditional | PDF ↗ |
| K081526 | FLOWCARE TLG REAGENT | Beckman Coulter, Inc. | 2008-08-14 | Abbreviated | PDF ↗ |
| K072869 | POINTCARE NOW SYSTEM | Pointcare Technologies, Inc. | 2008-01-14 | Traditional | PDF ↗ |
| K071562 | D3 HEMATOLOGY ANALYZER, MODEL D3 | Drew Scientific, Inc. | 2007-12-11 | Traditional | PDF ↗ |
| K071967 | SYSMEX XE-5000 | Sysmex America, Inc. | 2007-11-20 | Traditional | PDF ↗ |
| K071681 | CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 | Beckman Coulter, Inc. | 2007-10-04 | Special | PDF ↗ |
| K063407 | BC-3200 AUTO HEMATOLOGY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-06-11 | Traditional | PDF ↗ |
| K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 | Bd Biosciences | 2007-06-06 | Special | PDF ↗ |
| K071141 | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 | Bd Biosciences | 2007-06-06 | Special | PDF ↗ |
| K061616 | COULTER LH 780 HEMATOLOGY ANALYZER | Beckman Coulter, Inc. | 2006-10-04 | Abbreviated | PDF ↗ |
| K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 | Bd Biosciences | 2006-09-14 | Special | PDF ↗ |
| K060423 | CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES | Dakocytomation California, Inc. | 2006-08-15 | Traditional | PDF ↗ |
| K061574 | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 | Beckman Coulter, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K061667 | CELL-DYN RUBY SYSTEM | Abbott Laboratories | 2006-07-10 | Special | PDF ↗ |
| K061150 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES | Sysmex America, Inc. | 2006-07-06 | Traditional | PDF ↗ |
| K060375 | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 | Bd Biosciences | 2006-06-06 | Traditional | PDF ↗ |
| K060656 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES | Sysmex America, Inc. | 2006-05-10 | Traditional | PDF ↗ |
| K053497 | GUAVA EZCD4 SYSTEM | Guava Technologies, Inc. | 2006-04-14 | Traditional | PDF ↗ |
| K053308 | ABX MICROS CRP 200, OPTION IM | Horiba Abx | 2005-12-29 | Special | PDF ↗ |
| K050758 | CHEMPAQ XBC ANALYZER | Chempaq A/S | 2005-12-22 | Traditional | PDF ↗ |
| K052905 | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER | Beckman Coulter, Inc. | 2005-11-18 | Special | PDF ↗ |
| K051459 | SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER | Sysmex America, Inc. | 2005-09-23 | Traditional | PDF ↗ |
| K050421 | MS 4/5 HEMATOLOGY ANALYZER | Melet Schloesing Laboratories USA | 2005-08-31 | Abbreviated | PDF ↗ |
| K051199 | IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER | Sysmex America, Inc. | 2005-08-08 | Traditional | PDF ↗ |
| K051122 | ITAG MHC TETRAMER CMV ASSAY | Beckman Coulter, Inc. | 2005-08-01 | Traditional | PDF ↗ |
| K050436 | MS 9/5 HEMATOLOGY ANALYZER | Melet Schloesing Laboratories USA | 2005-07-27 | Abbreviated | PDF ↗ |
| K051215 | CELL-DYN SAPPHIRE SYSTEM | Abbott Laboratories | 2005-07-21 | Traditional | PDF ↗ |
| K050589 | RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER | Sysmex America, Inc. | 2005-05-04 | Traditional | PDF ↗ |
| K050719 | ABX PENTRA DX 120: OPTION SPS EVOLUTION | Horiba Abx | 2005-04-26 | Traditional | PDF ↗ |
| K050057 | COULTER LH 750 HEMATOLOGY ANALYZER | Beckman Coulter, Inc. | 2005-02-10 | Special | PDF ↗ |
| K043215 | FLOWCARE PLG CD4 REAGENT | Beckman Coulter, Inc. | 2005-01-19 | Abbreviated | PDF ↗ |
| K041882 | FLOWCARE SYSTEM | Pointcare Technologies, Inc. | 2004-11-23 | Traditional | PDF ↗ |
| K042724 | MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER | Beckman Coulter, Inc. | 2004-10-29 | Special | PDF ↗ |
| K042173 | COULTER A T 5DIFF CAP PIERCE (CP) | Beckman Coulter, Inc. | 2004-10-12 | Abbreviated | PDF ↗ |
| K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE | Bd Biosciences | 2004-09-17 | Traditional | PDF ↗ |
| K042251 | BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | Bayer Healthcare, LLC | 2004-09-17 | Special | PDF ↗ |
| K040725 | BD FACSCANTO SYSTEM | Becton Dickinson Immunocytometry Systems | 2004-09-10 | Traditional | PDF ↗ |
| K040026 | BD FACS 7-COLOR SETUP BEADS | Becton Dickinson Immunocytometry Systems | 2004-09-10 | Traditional | PDF ↗ |
| K040073 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004-03-18 | Traditional | PDF ↗ |
| K032214 | MEDONIC CA620/530 HEMATOLOGY ANALYZER | Boule Medical AB | 2004-01-29 | Traditional | PDF ↗ |
Product code GKZ · Class II · Hematology. Data: openFDA.