GKG
11 FDA 510(k) clearances · Product code
78 daysmedian time to decision
145 days90th percentile
11clearances measured
FDA profile
- Official device name
- Centrifuge, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6400
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1999: 1 · 2014: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SPUNCRIT (MODEL DRC-40) (K961803) | Micro Diagnostics Corp. | 1996-07-05 |
| MULTI-CENTRIFUGE (K955795) | Novonx, Inc. | 1996-03-29 |
| MICROHEMATOCRIT ROTOR (K930415) | Fisher Scientific Co., LLC | 1993-03-23 |
| SPUNCRIT (K925863) | bioMerieux, Inc. | 1993-02-05 |
| HERMLE Z230H (K920207) | Labnet Intl., Inc. | 1992-06-09 |
| CRITSPIN MICRO-HEMATOCRIT (K920759) | Stat-Spin Technologies | 1992-04-29 |
| HEMATASTAT C-70B (K913128) | Separation Technology, Inc. | 1991-09-23 |
| HEMATASTAT H-70 (K890849) | Separation Technology, Inc. | 1989-03-21 |
| HCT CENTRIFUGE (K822445) | Boehringer Mannheim Corp. | 1982-09-14 |
| QBC CENTRIFUGAL HEMATOLOGY SYSTEM (K821803) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-14 |
| CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY (K813033) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-04-09 |
Track GKG automatically
Every clearance here is in the API, with alerts when new ones post.