GKG — Centrifuge, Hematocrit Class II
FDA Device Classification
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 |