Panels › Hematology › Product code GKZ · Class 2
Counter, Differential Cell
Regulation 864.5220
4510(k)s in 12 months (381 all time)
1recalls in 12 months (247 all time)
211recalls that name a 510(k)
Top companies in GKZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2010 | K091313 | SYSMEX MODEL XT-4000I Sysmex America, Inc. | GKZ |
| Sep 18, 2009 | K090810 | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES Microgenics Corp. | GKZ |
| Jul 31, 2009 | K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 Bd Biosciences | GKZ |
| Apr 21, 2009 | K090013 | CHEMPAQ XBC ANALYZER Chempaq A/S, DK | GKZ |
| Apr 15, 2009 | K082091 | TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 Reametrix, Inc. | GKZ |
| Feb 4, 2009 | K081495 | CELL-DYN EMERALD SYSTEM Abbott Laboratories | GKZ |
| Feb 3, 2009 | K083420 | MEDONIC M SERIES Boule Medical AB | GKZ |
| Dec 19, 2008 | K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc. | GKZ |
| Oct 10, 2008 | K081890 | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER Sysmex America, Inc. | GKZ |
| Aug 29, 2008 | K081610 | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Aug 14, 2008 | K081526 | FLOWCARE TLG REAGENT Beckman Coulter, Inc. | GKZ |
| Aug 14, 2008 | K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 Bd Biosciences | GKZ |
| Jan 14, 2008 | K072869 | POINTCARE NOW SYSTEM Pointcare Technologies, Inc. | GKZ |
| Dec 11, 2007 | K071562 | D3 HEMATOLOGY ANALYZER, MODEL D3 Drew Scientific, Inc. | GKZ |
| Nov 20, 2007 | K071967 | SYSMEX XE-5000 Sysmex America, Inc. | GKZ |
| Oct 4, 2007 | K071681 | CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 Beckman Coulter, Inc. | GKZ |
| Jun 11, 2007 | K063407 | BC-3200 AUTO HEMATOLOGY ANALYZER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | GKZ |
| Jun 6, 2007 | K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 Bd Biosciences | GKZ |
| Jun 6, 2007 | K071141 | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 Bd Biosciences | GKZ |
| Oct 4, 2006 | K061616 | COULTER LH 780 HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| Sep 14, 2006 | K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 Bd Biosciences | GKZ |
| Aug 15, 2006 | K060423 | CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES Dakocytomation California, Inc. | GKZ |
| Jul 21, 2006 | K061574 | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc. | GKZ |
| Jul 10, 2006 | K061667 | CELL-DYN RUBY SYSTEM Abbott Laboratories | GKZ |
| Jul 6, 2006 | K061150 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES Sysmex America, Inc. | GKZ |
| Jun 6, 2006 | K060375 | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 Bd Biosciences | GKZ |
| May 10, 2006 | K060656 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES Sysmex America, Inc. | GKZ |
| Apr 14, 2006 | K053497 | GUAVA EZCD4 SYSTEM Guava Technologies, Inc. | GKZ |
| Dec 29, 2005 | K053308 | ABX MICROS CRP 200, OPTION IM Horiba Abx, FR | GKZ |
| Dec 22, 2005 | K050758 | CHEMPAQ XBC ANALYZER Chempaq A/S | GKZ |
| Nov 18, 2005 | K052905 | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| Sep 23, 2005 | K051459 | SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Aug 31, 2005 | K050421 | MS 4/5 HEMATOLOGY ANALYZER Melet Schloesing Laboratories USA | GKZ |
| Aug 8, 2005 | K051199 | IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Aug 1, 2005 | K051122 | ITAG MHC TETRAMER CMV ASSAY Beckman Coulter, Inc. | GKZ |
| Jul 27, 2005 | K050436 | MS 9/5 HEMATOLOGY ANALYZER Melet Schloesing Laboratories USA | GKZ |
| Jul 21, 2005 | K051215 | CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories | GKZ |
| May 4, 2005 | K050589 | RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Apr 26, 2005 | K050719 | ABX PENTRA DX 120: OPTION SPS EVOLUTION Horiba Abx, FR | GKZ |
| Feb 10, 2005 | K050057 | COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| Jan 19, 2005 | K043215 | FLOWCARE PLG CD4 REAGENT Beckman Coulter, Inc. | GKZ |
| Nov 23, 2004 | K041882 | FLOWCARE SYSTEM Pointcare Technologies, Inc. | GKZ |
| Oct 29, 2004 | K042724 | MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| Oct 12, 2004 | K042173 | COULTER A T 5DIFF CAP PIERCE (CP) Beckman Coulter, Inc. | GKZ |
| Sep 17, 2004 | K042251 | BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM Bayer Healthcare, LLC | GKZ |
| Sep 17, 2004 | K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE Bd Biosciences | GKZ |
| Sep 10, 2004 | K040725 | BD FACSCANTO SYSTEM Becton Dickinson Immunocytometry Systems | GKZ |
| Sep 10, 2004 | K040026 | BD FACS 7-COLOR SETUP BEADS Becton Dickinson Immunocytometry Systems | GKZ |
| Mar 18, 2004 | K040073 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) Sysmex America, Inc. | GKZ |
| Jan 29, 2004 | K032214 | MEDONIC CA620/530 HEMATOLOGY ANALYZER Boule Medical AB | GKZ |
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