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 |
|---|---|---|---|
| May 10, 1996 | K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| May 9, 1996 | K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM Ortho Diagnostic Systems, Inc. | GKZ |
| May 2, 1996 | K960427 | ABBOTT CELL-DYN 3500R SYSTEM Sequoia Turner Corp. | GKZ |
| Apr 30, 1996 | K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM Ortho Diagnostic Systems, Inc. | GKZ |
| Mar 28, 1996 | K955909 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE Dako Corp. | GKZ |
| Mar 22, 1996 | K953643 | HEMATIL 18 (H-18) Texas Intl. Laboratories, Inc. | GKZ |
| Mar 11, 1996 | K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS Serono Diagnostics, Inc. | GKZ |
| Feb 29, 1996 | K954688 | FLOW-COUNT COULTER FLUOROSPHERES Coulter Corp. | GKZ |
| Feb 20, 1996 | K950342 | TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems | GKZ |
| Feb 20, 1996 | K946055 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems | GKZ |
| Feb 5, 1996 | K955504 | QBC ACCUREAD SYSTEM Becton Dickinson Diagnostic Instrument Systems | GKZ |
| Jan 26, 1996 | K945212 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ Dako Corp. | GKZ |
| Dec 21, 1995 | K951073 | CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K950918 | CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K950917 | CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K950916 | CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 20, 1995 | K950919 | CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 19, 1995 | K945756 | IMAGN(TM) 2000 SYSTEM Buckman Co., Inc. | GKZ |
| Nov 20, 1995 | K953302 | FACS LOADER SYSTEM Becton Dickinson Immunocytometry Systems | GKZ |
| Nov 14, 1995 | K933878 | ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT Intracel Corp. | GKZ |
| Nov 3, 1995 | K954188 | OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL Immunotech Corp. | GKZ |
| Oct 20, 1995 | K946335 | OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES Immunotech, Inc. | GKZ |
| Oct 19, 1995 | K951496 | CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER Abbott Laboratories | GKZ |
| Oct 19, 1995 | K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT Buckman Co., Inc. | GKZ |
| Oct 13, 1995 | K953448 | ROCHE COBAS MICROS HEMATOLOGY ANALYZER Roche Diagnostic Systems, Inc. | GKZ |
| Oct 5, 1995 | K953340 | QBC ACCUTUBE Becton Dickinson Diagnostic Instrument Systems | GKZ |
| Sep 25, 1995 | K945205 | QBC ACCUTUBE Becton Dickinson Diagnostic Instrument Systems | GKZ |
| Sep 12, 1995 | K945678 | DATACELL 18MS Danam Electronics | GKZ |
| Sep 8, 1995 | K953498 | OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL Immunotech, Inc. | GKZ |
| Aug 25, 1995 | K950742 | CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT Coulter Corp. | GKZ |
| Aug 22, 1995 | K950057 | TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems | GKZ |
| Aug 14, 1995 | K952789 | OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES Immunotech Corp. | GKZ |
| Jul 20, 1995 | K950949 | COULTER MH025A Coulter Corp. | GKZ |
| Jul 5, 1995 | K952182 | OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES Immunotech, Inc. | GKZ |
| Jun 20, 1995 | K944128 | CALTAG CD4 R-PE MONOCLONAL ANTIBODY Caltag Laboratories, Inc. | GKZ |
| Jun 20, 1995 | K944127 | CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY Caltag Laboratories, Inc. | GKZ |
| Jun 20, 1995 | K944126 | CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES Caltag Laboratories, Inc. | GKZ |
| Jun 9, 1995 | K945837 | SYSMEX(TM) F-820, 520 Sysmex Corp. | GKZ |
| May 15, 1995 | K925255 | TRAX(TM) CD4 TEST KIT T Cell Diagnostics, Inc. | GKZ |
| May 5, 1995 | K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES Immunotech Corp. | GKZ |
| Apr 26, 1995 | K941713 | ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 26, 1995 | K932532 | ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 26, 1995 | K932531 | ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 26, 1995 | K932530 | ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Mar 6, 1995 | K943967 | ONYX Coulter Corp. | GKZ |
| Feb 3, 1995 | K943894 | SYSMEX K-4500 Sysmex Corp. | GKZ |
| Jan 25, 1995 | K945692 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) Dako Corp. | GKZ |
| Dec 14, 1994 | K941171 | TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Miles, Inc. | GKZ |
| Nov 21, 1994 | K944253 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 Dako Corp. | GKZ |
| Nov 21, 1994 | K943284 | MONOCLONAL MOUSE ANTI-HUMAN B-CELL Dako Corp. | GKZ |
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