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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2021 | Fenwal Inc Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells. Terminated |
GKT | None listed |
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