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 10, 1994 | K942797 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL Dako Corp. | GKZ |
| Oct 27, 1994 | K925909 | GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION Alicia Diagnostics, Inc. | GKZ |
| Sep 30, 1994 | K925274 | AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS Becton Dickinson Immunocytometry Systems | GKZ |
| Sep 9, 1994 | K933486 | FASCOUNT SYSTME Becton Dickinson Immunocytometry Systems | GKZ |
| May 2, 1994 | K936023 | SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER Toa Medical Electronics USA, Inc. | GKZ |
| Nov 22, 1993 | K933478 | TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 Miles, Inc. | GKZ |
| Nov 22, 1993 | K933475 | TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 Miles, Inc. | GKZ |
| Sep 1, 1993 | K923790 | FACSORT FLOW CYTOMETER Becton Dickinson Immunocytometry Systems | GKZ |
| Aug 23, 1993 | K932030 | COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY Coulter Corp. | GKZ |
| Aug 23, 1993 | K930913 | COULTER MH015 (DIFFERENTIAL CELL COUNTER) Coulter Corp. | GKZ |
| Aug 5, 1993 | K924587 | SIMULTEST CD3/ANTI-HLA-DR Becton Dickinson Immunocytometry Systems | GKZ |
| Jul 14, 1993 | K930309 | ABBOTT ENCOUNTER(TM)Q Abbott Laboratories | GKZ |
| Jul 6, 1993 | K926124 | CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON Coulter Corp. | GKZ |
| May 11, 1993 | K930148 | TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) Heraeus Kulzer, Inc. | GKZ |
| Feb 5, 1993 | K925528 | BIOVATION K-MANAGER Biovation, Inc. | GKZ |
| Feb 5, 1993 | K923773 | CELLEXIS HEMATOLOGY ANALYZER Technalysis, Inc. | GKZ |
| Feb 5, 1993 | K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 Coulter Immunology | GKZ |
| Feb 5, 1993 | K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 Coulter Immunology | GKZ |
| Jan 21, 1993 | K925344 | COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA Coulter Corp. | GKZ |
| Dec 29, 1992 | K921279 | CD4 CYTOSPHERES KIT Coulter Electronics, Inc. | GKZ |
| Sep 11, 1992 | K923237 | TECHNICON H*2 Heraeus Kulzer, Inc. | GKZ |
| Aug 17, 1992 | K922181 | COULTER MH009 Coulter Electronics, Inc. | GKZ |
| Jul 28, 1992 | K922085 | MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM Gen Trak, Inc. | GKZ |
| Jul 28, 1992 | K922084 | MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM Gen Trak, Inc. | GKZ |
| Jul 27, 1992 | K922704 | COULTER MAXM W/ AUTOLOADER Coulter Electronics, Inc. | GKZ |
| Jul 6, 1992 | K921567 | COULTER MH017 Coulter Electronics, Inc. | GKZ |
| Jun 19, 1992 | K914848 | CD4 MONOCLONAL ANTIBODIES Gen Trak, Inc. | GKZ |
| Jun 19, 1992 | K914846 | CD2 MONOCLONAL ANTIBODIES Gen Trak, Inc. | GKZ |
| May 15, 1992 | K920949 | SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 Heraeus Kulzer, Inc. | GKZ |
| Apr 29, 1992 | K920544 | SYSMEX HEMATOLOGY SYSTEM ACCESSORIES Toa Medical Electronics USA, Inc. | GKZ |
| Feb 6, 1992 | K913192 | SIMULTEST(TM) IMK-LYMPHOCYTE Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Jan 17, 1992 | K915071 | DIFFERENTIAL COUNTING BOARD Biovation, Inc. | GKZ |
| Dec 30, 1991 | K914744 | SYSMEX NE-1500, MODIFICATION Toa Medical Electronics USA, Inc. | GKZ |
| Dec 4, 1991 | K914014 | FACSTRAK FLOW CYTOMETER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Nov 22, 1991 | K913305 | CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER Unipath , Ltd. | GKZ |
| Oct 31, 1991 | K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC Coulter Immunology | GKZ |
| Oct 31, 1991 | K901189 | MONOCLONAL ANTIBODY ANTI-CD3 Sigma Chemical Co. | GKZ |
| Oct 31, 1991 | K901188 | MONOCLONAL ANTIBODY ANTI-CD5 Sigma Chemical Co. | GKZ |
| Oct 31, 1991 | K901187 | MONOCLONAL ANTIBODY ANTI-CD2 Sigma Chemical Co. | GKZ |
| Oct 31, 1991 | K901186 | MONOCLONAL ANTIBODY ANTI-CD19 Sigma Chemical Co. | GKZ |
| Oct 8, 1991 | K913259 | NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL Nova Biomedical Corp. | GKZ |
| Sep 13, 1991 | K911626 | SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER Serono Baker Diagnostics System | GKZ |
| Jul 9, 1991 | K911793 | COULTERCLONE Coulter Immunology | GKZ |
| Jun 17, 1991 | K911385 | COULTER(R) MH010 Coulter Electronics, Inc. | GKZ |
| May 20, 1991 | K904253 | ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY Ortho Diagnostic Systems, Inc. | GKZ |
| May 7, 1991 | K910834 | QBC AUTOREADER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Apr 12, 1991 | K910283 | DANAM DATACELL-18 Danam Electronics | GKZ |
| Dec 17, 1990 | K904390 | ANTI-HUMAN LEU-2A (CD8) PE Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Dec 11, 1990 | K904209 | SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Oct 4, 1990 | K903665 | CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY Unipath , Ltd. | GKZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.