FDA Product Code
FDA Product Code GKL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5200
510(k) Clearances — 130 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K802208 | LEUKOCYTE VOL. ANALYSIS APPARATUS | Coulter Electronics, Inc. | 1980-09-17 | Traditional | PDF ↗ |
| K801545 | ORTHO AUTOMATED CELL COUNTER | Ortho Instruments | 1980-09-09 | Traditional | PDF ↗ |
| K801155 | TECHNICON H6000 HEMATOLOGY SYSTEM | Technicon Instruments Corp. | 1980-06-09 | Traditional | PDF ↗ |
| K800346 | HEMOSAFE | Med Lab Systems, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K792668 | COULTER COUNTER-BLOOD CELL COUNTER | Coulter Electronics, Inc. | 1980-01-29 | Traditional | PDF ↗ |
| K792537 | COULTER COUNTER MODEL S PLUS | Coulter Electronics, Inc. | 1980-01-29 | Traditional | PDF ↗ |
| K791867 | ROYCO MODEL 921 CELL COUNTER | Royco Instruments | 1979-11-05 | Traditional | PDF ↗ |
| K790026 | ANALYZER, MODEL CC-720 | Sysmex Corp. | 1979-02-08 | Traditional | PDF ↗ |
| K782102 | HYCEL COUNTER 211 | Hycel, Inc. | 1979-01-03 | Traditional | PDF ↗ |
| K782101 | HYCEL COUNTER 222 | Hycel, Inc. | 1979-01-03 | Traditional | PDF ↗ |
| K782100 | HYCEL COUNTER 333 | Hycel, Inc. | 1979-01-03 | Traditional | PDF ↗ |
| K781562 | HEMACHECK | Vickers America Medical Corp. | 1978-11-15 | Traditional | PDF ↗ |
| K781628 | HEMO-W SYSTEM | Coulter Electronics, Inc. | 1978-10-27 | Traditional | PDF ↗ |
| K781146 | HEMAC LASER HEMATOLOGY SYSTEM | Ortho Instruments | 1978-09-14 | Traditional | PDF ↗ |
| K780911 | SYSMEX PLATELET COUNTER, PL-110 | Toa Medical Electronics USA, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K780909 | SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 | Toa Medical Electronics USA, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K780910 | SYSTEM AUTO. BLOOD CELL COUNTER CC-110 | Toa Medical Electronics USA, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K780224 | MICROCELL COUNTER MODEL CC-108 | Toa Medical Electronics USA, Inc. | 1978-05-19 | Traditional | PDF ↗ |
| K771512 | COUNTER MODEL S PLUS BLOOD CELL COUNTER | Coulter Electronics, Inc. | 1977-11-09 | Traditional | PDF ↗ |
| K771728 | AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 | Technicon Instruments Corp. | 1977-11-07 | Traditional | PDF ↗ |
| K771790 | DETECTOTERGE AZIDE FREE | J.T. Baker Chemical Co. | 1977-10-07 | Traditional | PDF ↗ |
| K771353 | PLATELET COUNTER & HEMATOCRIT ACCES. | Hycel, Inc. | 1977-08-10 | Traditional | PDF ↗ |
| K771107 | COUNTER 700 & HC-700 HEMO 0 REF. | Hycel, Inc. | 1977-07-11 | Traditional | PDF ↗ |
| K770666 | HEMALOG 8/90 | Technicon Instruments Corp. | 1977-05-06 | Traditional | PDF ↗ |
| K770385 | LATELET DETERMIN. KIT, CAT NO. 2521 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-08 | Traditional | PDF ↗ |
| K761289 | ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-28 | Traditional | PDF ↗ |
| K770034 | COUNTER, BLOOD CELL & HEMATOCRIT | Mallinckrodt Critical Care | 1977-02-16 | Traditional | PDF ↗ |
| K760765 | WHOLE BLOOD PLATELET COUNTER -2510 | Clay Adams, Div. Becton Dickinson & Co. | 1976-12-30 | Traditional | PDF ↗ |
| K760582 | HA/3 HEMATOLOGY ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-11 | Traditional | PDF ↗ |
| K760581 | HA/5 HEMATOLOGY ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 | Traditional | PDF ↗ |
Product code GKL · Class II · Hematology. Data: openFDA.