FDA Product Code
FDA Product Code GKG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6400
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961803 | SPUNCRIT (MODEL DRC-40) | Micro Diagnostics Corp. | 1996-07-05 | Traditional | PDF ↗ |
| K955795 | MULTI-CENTRIFUGE | Novonx, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K930415 | MICROHEMATOCRIT ROTOR | Fisher Scientific Co., LLC | 1993-03-23 | Traditional | PDF ↗ |
| K925863 | SPUNCRIT | bioMerieux, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K920207 | HERMLE Z230H | Labnet Intl., Inc. | 1992-06-09 | Traditional | PDF ↗ |
| K920759 | CRITSPIN MICRO-HEMATOCRIT | Stat-Spin Technologies | 1992-04-29 | Traditional | PDF ↗ |
| K913128 | HEMATASTAT C-70B | Separation Technology, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K890849 | HEMATASTAT H-70 | Separation Technology, Inc. | 1989-03-21 | Traditional | PDF ↗ |
| K822445 | HCT CENTRIFUGE | Boehringer Mannheim Corp. | 1982-09-14 | Traditional | PDF ↗ |
| K821803 | QBC CENTRIFUGAL HEMATOLOGY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-14 | Traditional | PDF ↗ |
| K813033 | CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-04-09 | Traditional | PDF ↗ |
Product code GKG · Class II · Hematology. Data: openFDA.