Panels › Hematology › Product code GKT · Class 2
Separator, Automated, Blood Cell, Diagnostic
Regulation 864.9245
0510(k)s in 12 months (10 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in GKT
| Company | 510(k)s | Recalls |
|---|---|---|
| Fresenius Kabi AG | 2 | 0 |
| Intl. Business Machines | 2 | 0 |
| Travenol Laboratories, S.A. | 2 | 0 |
| Cryosan, Inc. | 1 | 0 |
| Fenwal Inc | 0 | 1 |
| Metrix Teknika, Inc. | 1 | 0 |
| Pheragen Technology Corp. | 1 | 0 |
| Terumo America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2020 | K200530 | AMICUS Separator System Fresenius Kabi AG | GKT |
| Nov 23, 2016 | K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished Fresenius Kabi USA,Llc | GKT |
| Sep 30, 1982 | K822521 | AUTOMATED BLOOD CELL SEPARATOR Cryosan, Inc. | GKT |
| Apr 27, 1982 | K820396 | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR Pheragen Technology Corp. | GKT |
| Oct 31, 1980 | K801233 | CELLTRIFUGE II Travenol Laboratories, S.A. | GKT |
| Aug 10, 1979 | K791106 | STERILE, DISPOSABLE CENTRIFUGE BOWL Travenol Laboratories, S.A. | GKT |
| May 24, 1979 | K790105 | TERUMO IMUGARD Terumo America, Inc. | GKT |
| Jan 17, 1979 | K781803 | FILTER, EYRPUR DISPOSABLE LEUKOCITE Metrix Teknika, Inc. | GKT |
| Sep 6, 1977 | K771258 | BLOOD CELL SEPARATOR 2997 Intl. Business Machines | GKT |
| Jan 10, 1977 | K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 Intl. Business Machines | GKT |
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