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 | September 11, 2020 |
| K162462 | fresenius kabi usa | AMICUS Separator System, AMICUS Separator System; Refurbished | November 23, 2016 |
| K822521 | cryosan | AUTOMATED BLOOD CELL SEPARATOR | September 30, 1982 |
| K820396 | pheragen technology | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | April 27, 1982 |
| K801233 | travenol laboratories | CELLTRIFUGE II | October 31, 1980 |
| K791106 | travenol laboratories | STERILE, DISPOSABLE CENTRIFUGE BOWL | August 10, 1979 |
| K790105 | terumo america | TERUMO IMUGARD | May 24, 1979 |
| K781803 | metrix teknika | FILTER, EYRPUR DISPOSABLE LEUKOCITE | January 17, 1979 |
| K771258 | intl. business machines | BLOOD CELL SEPARATOR 2997 | September 6, 1977 |
| K760856 | intl. business machines | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | January 10, 1977 |