Panels › Hematology › Product code GKL · Class 2
Counter, Cell, Automated (Particle Counter)
Regulation 864.5200
0510(k)s in 12 months (130 all time)
0recalls in 12 months (10 all time)
7recalls that name a 510(k)
Top companies in GKL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 1980 | K802208 | LEUKOCYTE VOL. ANALYSIS APPARATUS Coulter Electronics, Inc. | GKL |
| Sep 9, 1980 | K801545 | ORTHO AUTOMATED CELL COUNTER Ortho Instruments | GKL |
| Jun 9, 1980 | K801155 | TECHNICON H6000 HEMATOLOGY SYSTEM Technicon Instruments Corp. | GKL |
| Apr 16, 1980 | K800346 | HEMOSAFE Med Lab Systems, Inc. | GKL |
| Jan 29, 1980 | K792668 | COULTER COUNTER-BLOOD CELL COUNTER Coulter Electronics, Inc. | GKL |
| Jan 29, 1980 | K792537 | COULTER COUNTER MODEL S PLUS Coulter Electronics, Inc. | GKL |
| Nov 5, 1979 | K791867 | ROYCO MODEL 921 CELL COUNTER Royco Instruments | GKL |
| Feb 8, 1979 | K790026 | ANALYZER, MODEL CC-720 Sysmex Corp. | GKL |
| Jan 3, 1979 | K782102 | HYCEL COUNTER 211 Hycel, Inc. | GKL |
| Jan 3, 1979 | K782101 | HYCEL COUNTER 222 Hycel, Inc. | GKL |
| Jan 3, 1979 | K782100 | HYCEL COUNTER 333 Hycel, Inc. | GKL |
| Nov 15, 1978 | K781562 | HEMACHECK Vickers America Medical Corp. | GKL |
| Oct 27, 1978 | K781628 | HEMO-W SYSTEM Coulter Electronics, Inc. | GKL |
| Sep 14, 1978 | K781146 | HEMAC LASER HEMATOLOGY SYSTEM Ortho Instruments | GKL |
| Jun 28, 1978 | K780911 | SYSMEX PLATELET COUNTER, PL-110 Toa Medical Electronics USA, Inc. | GKL |
| Jun 28, 1978 | K780910 | SYSTEM AUTO. BLOOD CELL COUNTER CC-110 Toa Medical Electronics USA, Inc. | GKL |
| Jun 28, 1978 | K780909 | SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 Toa Medical Electronics USA, Inc. | GKL |
| May 19, 1978 | K780224 | MICROCELL COUNTER MODEL CC-108 Toa Medical Electronics USA, Inc. | GKL |
| Nov 9, 1977 | K771512 | COUNTER MODEL S PLUS BLOOD CELL COUNTER Coulter Electronics, Inc. | GKL |
| Nov 7, 1977 | K771728 | AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 Technicon Instruments Corp. | GKL |
| Oct 7, 1977 | K771790 | DETECTOTERGE AZIDE FREE J.T. Baker Chemical Co. | GKL |
| Aug 10, 1977 | K771353 | PLATELET COUNTER & HEMATOCRIT ACCES. Hycel, Inc. | GKL |
| Jul 11, 1977 | K771107 | COUNTER 700 & HC-700 HEMO 0 REF. Hycel, Inc. | GKL |
| May 6, 1977 | K770666 | HEMALOG 8/90 Technicon Instruments Corp. | GKL |
| Apr 8, 1977 | K770385 | LATELET DETERMIN. KIT, CAT NO. 2521 Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Mar 28, 1977 | K761289 | ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Feb 16, 1977 | K770034 | COUNTER, BLOOD CELL & HEMATOCRIT Mallinckrodt Critical Care | GKL |
| Dec 30, 1976 | K760765 | WHOLE BLOOD PLATELET COUNTER -2510 Clay Adams, Div. Becton Dickinson & Co. | GKL |
| Nov 11, 1976 | K760582 | HA/3 HEMATOLOGY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Nov 9, 1976 | K760581 | HA/5 HEMATOLOGY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
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