Separator, Automated, Blood Cell, Diagnostic
FDA product code GKT · Class II (moderate risk) · 21 CFR 864.9245 · Hematology
10510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200530 | AMICUS Separator SystemGKT · Traditional | Fresenius Kabi AG | 09/11/2020SE |
| K162462 | AMICUS Separator System, AMICUS Separator System; RefurbishedGKT · Traditional | Fresenius Kabi USA,Llc | 11/23/2016SE |
| K822521 | Automated Blood Cell SeparatorGKT · Traditional | Cryosan, Inc. | 09/30/1982SE |
| K820396 | Automated Blood Cell Separ. Disp. SftwrGKT · Traditional | Pheragen Technology Corp. | 04/27/1982SE |
| K801233 | Celltrifuge IIGKT · Traditional | Travenol Laboratories, S.A. | 10/31/1980SE |
| K791106 | Sterile, Disposable Centrifuge BowlGKT · Traditional | Travenol Laboratories, S.A. | 08/10/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | Terumo America, Inc. | 05/24/1979SE |
| K781803 | Filter, Eyrpur Disposable LeukociteGKT · Traditional | Metrix Teknika, Inc. | 01/17/1979SE |
| K771258 | Blood Cell Separator 2997GKT · Traditional | Intl. Business Machines | 09/06/1977SE |
| K760856 | Blood Cell Processor Model 2 IBM 2991GKT · Traditional | Intl. Business Machines | 01/10/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1343-2021 Class II | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the…Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure… | Fenwal Inc | 02/25/2021Terminated |