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 |
|---|---|---|---|
| Nov 24, 2003 | K030263 | IMMUNICON CELLTRACKS ANALYZER Immunicon Corp. | GKZ |
| Sep 26, 2003 | K032342 | COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| Sep 8, 2003 | K032524 | ADVIA 60 HEMATOLOGY ANALYZER Bayer Healthcare, LLC | GKZ |
| Sep 8, 2003 | K032039 | IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Aug 13, 2003 | K032000 | COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| Jul 24, 2003 | K032013 | COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER Beckman Coulter, Inc. | GKZ |
| May 21, 2003 | K030828 | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) Beckman Coulter, Inc. | GKZ |
| May 12, 2003 | K030513 | CELL-DYN 1800 SYSTEM Abbott Laboratories | GKZ |
| Apr 21, 2003 | K030606 | COULTER LH 750 BODY FLUIDS APPLICATION Beckman Coulter, Inc. | GKZ |
| Apr 17, 2003 | K030291 | COULTER ACT 5DIFF AUTOLOADER (AL) Beckman Coulter, Inc. | GKZ |
| Apr 8, 2003 | K030799 | MICROS 60 Abx Diagnostics, FR | GKZ |
| Mar 4, 2003 | K030408 | CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A Beckman Coulter, Inc. | GKZ |
| Jan 31, 2003 | K030144 | MODIFICATION TO PENTRA 60 AND PENTRA 60C+ Abx Diagnostics, FR | GKZ |
| Jan 3, 2003 | K024002 | PENTRA 80 Abx Diagnostics, FR | GKZ |
| Oct 15, 2002 | K022668 | ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD Bayer Diagnostics Corp. | GKZ |
| Sep 11, 2002 | K022528 | IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ Iq Corp. | GKZ |
| Jul 29, 2002 | K022200 | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 Abx Diagnostics, FR | GKZ |
| Jul 29, 2002 | K022161 | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc. | GKZ |
| Jun 25, 2002 | K021241 | SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I Sysmex Corporation of America | GKZ |
| Apr 12, 2002 | K020496 | HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY Sysmex Corporation of America | GKZ |
| Sep 28, 2001 | K012934 | CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE Abbott Laboratories | GKZ |
| Sep 21, 2001 | K012904 | ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION Bayer Diagnostics Corp. | GKZ |
| Jul 9, 2001 | K011342 | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc. | GKZ |
| Jun 6, 2001 | K010953 | CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY Abbott Laboratories | GKZ |
| Apr 13, 2001 | K010765 | COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 Beckman Coulter, Inc. | GKZ |
| Feb 5, 2001 | K003796 | ADVIA 120 HEMATOLOGY Bayer Corp. | GKZ |
| Dec 26, 2000 | K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Oct 26, 2000 | K002646 | ABX MICROS CRP Abx Diagnostics | GKZ |
| May 18, 2000 | K000611 | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER Bd Biosciences | GKZ |
| May 5, 2000 | K000897 | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE Bd Biosciences | GKZ |
| Apr 20, 2000 | K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES Coulter Corp. | GKZ |
| Nov 9, 1999 | K992875 | SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER Sysmex Corp. | GKZ |
| Oct 15, 1999 | K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Sep 24, 1999 | K992444 | MODIFICATION OF: CELL-DYN 1200 SYSTEM Abbott Laboratories | GKZ |
| Sep 23, 1999 | K992849 | QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Aug 11, 1999 | K991839 | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Jul 9, 1999 | K991605 | CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION Abbott Laboratories | GKZ |
| Jul 1, 1999 | K991539 | EXCELL 22 Mwi, Inc. | GKZ |
| Jun 23, 1999 | K991142 | CELL-DYN 1200 SYSTEM Abbott Laboratories | GKZ |
| Jun 21, 1999 | K991454 | MOUSE IGG1 NEGATIVE CONTROLS Dako Corp. | GKZ |
| Jun 21, 1999 | K991402 | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 Dako Corp. | GKZ |
| Apr 26, 1999 | K990327 | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS Coulter Corp. | GKZ |
| Apr 13, 1999 | K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA Coulter Corp. | GKZ |
| Apr 1, 1999 | K990352 | COULTER AC T DIFF 2 ANALYZER Coulter Corp. | GKZ |
| Mar 31, 1999 | K990311 | VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Nov 9, 1998 | K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 Coulter Corp. | GKZ |
| Nov 5, 1998 | K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 Coulter Corp. | GKZ |
| Nov 3, 1998 | K983562 | MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 Cdc Technologies, Inc. | GKZ |
| Sep 24, 1998 | K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL Coulter Corp. | GKZ |
| Sep 22, 1998 | K982802 | BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | GKZ |
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