GKG — Centrifuge, Hematocrit Class II
FDA product code GKG covers "Centrifuge, Hematocrit", a Class II medical device regulated under 21 CFR 864.6400. Submissions are reviewed by the Hematology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKG
- Device Class
- Class II
- Regulation Number
- 864.6400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961803 | micro diagnostics | SPUNCRIT (MODEL DRC-40) | July 5, 1996 |
| K955795 | novonx | MULTI-CENTRIFUGE | March 29, 1996 |
| K930415 | fisher scientific co | MICROHEMATOCRIT ROTOR | March 23, 1993 |
| K925863 | biomerieux | SPUNCRIT | February 5, 1993 |
| K920207 | labnet intl | HERMLE Z230H | June 9, 1992 |
| K920759 | stat-spin technologies | CRITSPIN MICRO-HEMATOCRIT | April 29, 1992 |
| K913128 | separation technology | HEMATASTAT C-70B | September 23, 1991 |
| K890849 | separation technology | HEMATASTAT H-70 | March 21, 1989 |
| K821803 | bd becton dickinson vacutainer systems preanalytic | QBC CENTRIFUGAL HEMATOLOGY SYSTEM | September 14, 1982 |
| K822445 | boehringer mannheim | HCT CENTRIFUGE | September 14, 1982 |
| K813033 | bd becton dickinson vacutainer systems preanalytic | CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY | April 9, 1982 |