FDA Product Code
FDA Product Code GKT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9245
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200530 | AMICUS Separator System | Fresenius Kabi AG | 2020-09-11 | Traditional | PDF ↗ |
| K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | Fresenius Kabi USA,Llc | 2016-11-23 | Traditional | PDF ↗ |
| K822521 | AUTOMATED BLOOD CELL SEPARATOR | Cryosan, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K820396 | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | Pheragen Technology Corp. | 1982-04-27 | Traditional | PDF ↗ |
| K801233 | CELLTRIFUGE II | Travenol Laboratories, S.A. | 1980-10-31 | Traditional | PDF ↗ |
| K791106 | STERILE, DISPOSABLE CENTRIFUGE BOWL | Travenol Laboratories, S.A. | 1979-08-10 | Traditional | PDF ↗ |
| K790105 | TERUMO IMUGARD | Terumo America, Inc. | 1979-05-24 | Traditional | PDF ↗ |
| K781803 | FILTER, EYRPUR DISPOSABLE LEUKOCITE | Metrix Teknika, Inc. | 1979-01-17 | Traditional | PDF ↗ |
| K771258 | BLOOD CELL SEPARATOR 2997 | Intl. Business Machines | 1977-09-06 | Traditional | PDF ↗ |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Intl. Business Machines | 1977-01-10 | Traditional | PDF ↗ |
Product code GKT · Class II · Hematology. Data: openFDA.