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 |
|---|---|---|---|
| Jan 1, 1986 | K854368 | CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER Abbott Diagnostics | GKZ |
| Jan 1, 1986 | K854242 | QBC CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Nov 12, 1985 | K853304 | 21 HEMATOLOGY REAGENTS In Vitro Diagnostics, Inc. | GKZ |
| Sep 17, 1985 | K852371 | CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY Abbott Diagnostics | GKZ |
| May 20, 1985 | K850354 | SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS Toa Medical Electronics USA, Inc. | GKZ |
| Apr 1, 1985 | K844910 | SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - Toa Medical Electronics USA, Inc. | GKZ |
| Mar 5, 1985 | K844645 | QBC CENTRIFUGAL HEMATOLOGY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Sep 5, 1984 | K841852 | AUTOLYZER 800 Geometric Data, Div. Smithkline Corp. | GKZ |
| Jul 27, 1984 | K842636 | TECHNICON H*1 SYSTEM Technicon Instruments Corp. | GKZ |
| Apr 30, 1984 | K840195 | FACS ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKZ |
| Jan 13, 1984 | K833618 | ORTHO ELT-8/DS HEMATOLOGY ANALYZER Ortho Diagnostic Systems, Inc. | GKZ |
| Jan 10, 1984 | K833600 | COULTER COUNTER MODEL S-PLUS V Coulter Electronics, Inc. | GKZ |
| Jul 26, 1983 | K831271 | ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG Ortho Diagnostic Systems, Inc. | GKZ |
| Dec 28, 1982 | K823355 | COULTER-COUNTER #S PLUS IV & LYSE S +D Coulter Electronics, Inc. | GKZ |
| Jun 25, 1982 | K821186 | PENETRAK TM Syva Co. | GKZ |
| Jan 21, 1981 | K803219 | ADC-500 AUTOMATED DIFFER. CELL CNTR. SY. Abbott Laboratories | GKZ |
| Apr 4, 1980 | K800533 | ADD OF RETICULOCYTE COUNT/CAPABILITIES Abbott Laboratories | GKZ |
| Feb 5, 1980 | K800121 | TECHNICON C/90 SYSTEM Technicon Instruments Corp. | GKZ |
| Oct 30, 1979 | K791903 | COULTER DIFF3 SYS. (COULTER #7400003) Coulter Electronics, Inc. | GKZ |
| Sep 4, 1979 | K791041 | HEMATRAK ABNORMAL RECOGNITION Geometric Data, Div. Smithkline Corp. | GKZ |
| Jul 17, 1979 | K791108 | CONTEXT FILTER Geometric Data, Div. Smithkline Corp. | GKZ |
| Jul 17, 1979 | K790816 | HEMATRAK MODEL 480 Geometric Data, Div. Smithkline Corp. | GKZ |
| Jan 3, 1979 | K782050 | PRINTER, TEK PRO TEK TALLY II Tekpro | GKZ |
| May 19, 1978 | K780577 | PLATELETS/CU MM Geometric Data, Div. Smithkline Corp. | GKZ |
| Oct 18, 1977 | K761207 | HEMATRAK RBC MORPHOLOGY Geometric Data, Div. Smithkline Corp. | GKZ |
| Aug 4, 1977 | K770244 | AUTO DIFFERENTIAL CELL COUNTER SYSTEM Abbott Laboratories | GKZ |
| Jul 1, 1977 | K770680 | HEMATRAK Geometric Data, Div. Smithkline Corp. | GKZ |
| Jun 17, 1977 | K770550 | ATYPIA PROFILE MONITOR Geometric Data, Div. Smithkline Corp. | GKZ |
| Jun 3, 1977 | K770701 | HEMATRAK MODEL 125 Geometric Data, Div. Smithkline Corp. | GKZ |
| Jun 2, 1977 | K770869 | ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION Geometric Data, Div. Smithkline Corp. | GKZ |
| Feb 28, 1977 | K761208 | HEMATRAK MATURITY PROFILE OPTION Geometric Data, Div. Smithkline Corp. | GKZ |
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