GKT — Separator, Automated, Blood Cell, Diagnostic Class II
FDA product code GKT covers "Separator, Automated, Blood Cell, Diagnostic", a Class II medical device regulated under 21 CFR 864.9245. Submissions are reviewed by the Hematology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKT
- Device Class
- Class II
- Regulation Number
- 864.9245
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200530 | Fresenius Kabi | AMICUS Separator System | Sep 11, 2020 |
| K162462 | Fresenius Kabi Usa | AMICUS Separator System, AMICUS Separator System; Refurbished | Nov 23, 2016 |
| K822521 | Cryosan | AUTOMATED BLOOD CELL SEPARATOR | Sep 30, 1982 |
| K820396 | Pheragen Technology | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | Apr 27, 1982 |
| K801233 | Travenol Laboratories | CELLTRIFUGE II | Oct 31, 1980 |
| K791106 | Travenol Laboratories | STERILE, DISPOSABLE CENTRIFUGE BOWL | Aug 10, 1979 |
| K790105 | Terumo America | TERUMO IMUGARD | May 24, 1979 |
| K781803 | Metrix Teknika | FILTER, EYRPUR DISPOSABLE LEUKOCITE | Jan 17, 1979 |
| K771258 | Intl. Business Machines | BLOOD CELL SEPARATOR 2997 | Sep 6, 1977 |
| K760856 | Intl. Business Machines | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Jan 10, 1977 |