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 15, 1990 | K900802 | ANTI-HUMAN LEU-3A (CD4) FITC Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Apr 16, 1990 | K900684 | RDW AND MPV INDICES ON HEMAT 12 Texas Intl. Laboratories, Inc. | GKZ |
| Apr 16, 1990 | K900276 | EXACT ONE(TM) HEMATOLOGY ANALYZER Exact Science, Inc. | GKZ |
| Apr 2, 1990 | K900078 | SIMULTEST IMK PLUS(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Mar 30, 1990 | K896873 | COULTER JT3 Coulter Corp. | GKZ |
| Mar 14, 1990 | K900593 | TECHNICON H*2(TM) SYSTEM Technicon Instruments Corp. | GKZ |
| Mar 2, 1990 | K893853 | COULTER CLONE T8 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Mar 2, 1990 | K893852 | COULTER CLONE T4 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Feb 12, 1990 | K894179 | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Dec 29, 1989 | K895917 | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI Coulter Immunology | GKZ |
| Dec 29, 1989 | K890349 | SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN Becton Dickinson Immunocytometry Systems | GKZ |
| Oct 10, 1989 | K895127 | ARGOS Abx, Inc. | GKZ |
| Aug 15, 1989 | K884605 | COULTER CLONE MO2 Coulter Immunology | GKZ |
| Aug 3, 1989 | K891276 | QBC MALARIA SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Jun 20, 1989 | K893423 | QBC III CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Jun 13, 1989 | K892205 | DANAM VECTOR-8+ Danam Electronics | GKZ |
| Apr 18, 1989 | K890491 | CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER Abbott Diagnostics | GKZ |
| Feb 16, 1989 | K885028 | COULTER 5P CONTROL Coulter Electronics, Inc. | GKZ |
| Feb 3, 1989 | K884020 | COULTER CLONE B4 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Feb 3, 1989 | K883753 | COULTER CLONE T1 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Feb 3, 1989 | K883710 | COULTER CLONE T3 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Dec 28, 1988 | K885093 | COULTER STKS Coulter Electronics, Inc. | GKZ |
| Dec 27, 1988 | K884346 | CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI Coulter Immunology | GKZ |
| Dec 5, 1988 | K884006 | HEMAT 12 Texas Intl. Laboratories, Inc. | GKZ |
| Dec 5, 1988 | K883997 | SYSMEX NE-8000 Toa Medical Electronics USA, Inc. | GKZ |
| Nov 30, 1988 | K883177 | H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER Texas Intl. Laboratories, Inc. | GKZ |
| Sep 14, 1988 | K882557 | COULTER CLONE B1 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Sep 7, 1988 | K882612 | SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER Baker Instructions Corp. | GKZ |
| Sep 7, 1988 | K882579 | HEMATRAK(R) MODEL 590 Priority Service Systems | GKZ |
| Aug 25, 1988 | K882370 | SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER Toa Medical Electronics USA, Inc. | GKZ |
| May 2, 1988 | K880616 | MINOS AUTOMATIC CELL COUNTER Abx, Inc. | GKZ |
| Apr 7, 1988 | K875346 | AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) Contraves Medical Instruments, Inc. | GKZ |
| Apr 4, 1988 | K880507 | COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER Coulter Electronics, Inc. | GKZ |
| Mar 9, 1988 | K875047 | COULTER CLONE T11 MONOCLONAL ANTIBODY Coulter Electronics, Inc. | GKZ |
| Feb 19, 1988 | K874838 | COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. Coulter Electronics, Inc. | GKZ |
| Feb 18, 1988 | K874763 | CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER Instrumentation Laboratory CO | GKZ |
| Jan 11, 1988 | K874147 | QBC BLOOD BANK SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Jan 5, 1988 | K874427 | QBC SYSTEM HEMOGLOBIN Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Nov 25, 1987 | K873734 | SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER Toa Medical Electronics USA, Inc. | GKZ |
| Nov 6, 1987 | K873256 | MICRO-COUNT DIFFHE Toni Diagnostics, Inc. | GKZ |
| Aug 6, 1987 | K872761 | CELL-DYN 610 HEMATOLOGY ANALYZER Abbott Diagnostics | GKZ |
| Jul 16, 1987 | K864579 | MINOS AUTOMATIC CELL COUNTER Abx, Inc. | GKZ |
| Jul 2, 1987 | K871837 | COULTER COUNTER MODEL S-PLUS STKR Coulter Electronics, Inc. | GKZ |
| Jun 24, 1987 | K871600 | SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY. Toa Medical Electronics USA, Inc. | GKZ |
| Mar 17, 1987 | K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER Abbott Diagnostics | GKZ |
| Feb 24, 1986 | K855117 | SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM Toa Medical Electronics USA, Inc. | GKZ |
| Feb 24, 1986 | K855116 | SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM Toa Medical Electronics USA, Inc. | GKZ |
| Feb 5, 1986 | K853027 | TECHNICON H*1 SYSTEM (MPXI) Technicon Instruments Corp. | GKZ |
| Jan 24, 1986 | K853029 | TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA Technicon Instruments Corp. | GKZ |
| Jan 21, 1986 | K852988 | TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. Technicon Instruments Corp. | GKZ |
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