Panels › Hematology › Product code GKG · Class 2
Centrifuge, Hematocrit
Regulation 864.6400
0510(k)s in 12 months (11 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in GKG
| Company | 510(k)s | Recalls |
|---|---|---|
| Hettich Instruments Management I | 0 | 4 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| Separation Technology, Inc. | 2 | 0 |
| bioMerieux, Inc. | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Fisher Scientific Co., LLC | 1 | 0 |
| Labnet Intl., Inc. | 1 | 0 |
| Micro Diagnostics Corp. | 1 | 0 |
| Novonx, Inc. | 1 | 0 |
| Stat-Spin Technologies | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 5, 1996 | K961803 | SPUNCRIT (MODEL DRC-40) Micro Diagnostics Corp. | GKG |
| Mar 29, 1996 | K955795 | MULTI-CENTRIFUGE Novonx, Inc. | GKG |
| Mar 23, 1993 | K930415 | MICROHEMATOCRIT ROTOR Fisher Scientific Co., LLC | GKG |
| Feb 5, 1993 | K925863 | SPUNCRIT bioMerieux, Inc. | GKG |
| Jun 9, 1992 | K920207 | HERMLE Z230H Labnet Intl., Inc. | GKG |
| Apr 29, 1992 | K920759 | CRITSPIN MICRO-HEMATOCRIT Stat-Spin Technologies | GKG |
| Sep 23, 1991 | K913128 | HEMATASTAT C-70B Separation Technology, Inc. | GKG |
| Mar 21, 1989 | K890849 | HEMATASTAT H-70 Separation Technology, Inc. | GKG |
| Sep 14, 1982 | K822445 | HCT CENTRIFUGE Boehringer Mannheim Corp. | GKG |
| Sep 14, 1982 | K821803 | QBC CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKG |
| Apr 9, 1982 | K813033 | CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY Bd Becton Dickinson Vacutainer Systems Preanalytic | GKG |
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