ClearanceBrief
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)
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Top companies in GKZ

Company510(k)sRecalls
Beckman Coulter28123
Abbott Laboratories2454
Sysmex America, Inc.225
Siemens Healthcare Diagnostics323
Coulter Corp.230
Becton Dickinson Immunocytometry Systems210
Ortho Diagnostic Systems, Inc.160
Bd Becton Dickinson Vacutainer Systems Preanalytic150
Abx Diagnostics95
Coulter Electronics, Inc.140
Decided510(k)Device and applicantCode
Aug 21, 1998K981568MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
Cdc Technologies, Inc.
GKZ
Jul 22, 1998K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
Dako Corp.
GKZ
Jul 20, 1998K982231STATUSFLOW
R&D Systems, Inc.
GKZ
Jun 29, 1998K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
Abbott Laboratories
GKZ
May 22, 1998K980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
Becton Dickinson Immunocytometry Systems
GKZ
Apr 24, 1998K980614ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
Abbott Laboratories
GKZ
Mar 11, 1998K974360MULTITEST CD3/CD8/CD45/CD4
Becton Dickinson Immunocytometry Systems
GKZ
Feb 17, 1998K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
Becton Dickinson Immunocytometry Systems
GKZ
Dec 1, 1997K971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
Becton Dickinson Immunocytometry Systems
GKZ
Nov 25, 1997K971110TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
Becton Dickinson Immunocytometry Systems
GKZ
Nov 21, 1997K970326TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
Becton Dickinson Immunocytometry Systems
GKZ
Nov 21, 1997K965053TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES
Becton Dickinson Immunocytometry Systems
GKZ
Oct 29, 1997K973634COULTER AC.T DIFF ANALYZER
Coulter Corp.
GKZ
Oct 22, 1997K970742TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
Becton Dickinson Immunocytometry Systems
GKZ
Sep 16, 1997K972354ABBOTT CELL-DYN 3200 SYSTEM
Abbott Laboratories
GKZ
Aug 26, 1997K971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
Sysmex Corp.
GKZ
Aug 26, 1997K970836TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
Becton Dickinson Immunocytometry Systems
GKZ
Aug 12, 1997K971152ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
Abbott Laboratories
GKZ
Jul 14, 1997K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
Ortho Diagnostic Systems, Inc.
GKZ
Jun 24, 1997K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
Dako Corp.
GKZ
May 14, 1997K965232CALTAG CAL-LYSE
Caltag Laboratories, Inc.
GKZ
Mar 6, 1997K964988COULTER AC.T SERIES ANALYZER
Coulter Corp.
GKZ
Mar 6, 1997K960072SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
Biochem Immunosystems (U.S.), Inc.
GKZ
Mar 6, 1997K951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
Ortho Diagnostic Systems, Inc.
GKZ
Jan 22, 1997K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
Ortho Diagnostic Systems, Inc.
GKZ
Jan 22, 1997K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
Coulter Corp.
GKZ
Jan 17, 1997K964856CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
Caltag Laboratories, Inc.
GKZ
Jan 6, 1997K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
Coulter Corp.
GKZ
Jan 6, 1997K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
Coulter Corp.
GKZ
Dec 23, 1996K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
Coulter Corp.
GKZ
Dec 12, 1996K963963MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
Becton Dickinson Immunocytometry Systems
GKZ
Nov 25, 1996K963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
Caltag Laboratories, Inc.
GKZ
Nov 4, 1996K962633VEGA HEMATOLOGY ANALYZER
Abx, Inc., FR
GKZ
Oct 18, 1996K961439ABBOTT CELL-DYN 4000 SYSTEM
Abbott Diagnostics
GKZ
Oct 8, 1996K955715CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
Abbott Laboratories
GKZ
Aug 23, 1996K954594RETICULOCYTE METHOD, RBC INDICES
Bayer Corp.
GKZ
Jul 22, 1996K961278COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
Coulter Corp.
GKZ
Jul 16, 1996K961701MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
Dako Corp.
GKZ
Jul 1, 1996K961610R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
R&D Systems, Inc.
GKZ
Jun 14, 1996K961435MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
Dako Corp.
GKZ
Jun 14, 1996K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
Dako Corp.
GKZ
Jun 7, 1996K961623FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
Becton Dickinson Monoclonal Center
GKZ
Jun 5, 1996K942525MEDICOUNT DEKA HEMATOLOGY ANALYZER
Cea America Corp.
GKZ
May 20, 1996K955673CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
Abbott Laboratories
GKZ
May 17, 1996K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
Dako Corp.
GKZ
May 17, 1996K960827QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
Becton Dickinson Diagnostic Instrument Systems
GKZ
May 13, 1996K953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
Intl. Remote Imaging Systems
GKZ
May 13, 1996K951100ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
Ortho Diagnostic Systems, Inc.
GKZ
May 13, 1996K950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
Ortho Diagnostic Systems, Inc.
GKZ
May 13, 1996K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
Ortho Diagnostic Systems, Inc.
GKZ

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