KSK
5 FDA 510(k) clearances · Product code
65 daysmedian time to decision
119 days90th percentile
5clearances measured
FDA profile
- Official device name
- Solution, Stabilized Enzyme
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9400
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (K813342) | Gamma Biologicals, Inc. | 1982-03-04 |
| FREEZE DRIED FICIN (K813404) | Biological Corp. of America | 1982-02-10 |
| FREEZE DRIED PAPAIN (K810803) | Biological Corp. of America | 1981-07-21 |
| AUTOMATED ENZYME (K780962) | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
| AUTOZYME (K760123) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Track KSK automatically
Every clearance here is in the API, with alerts when new ones post.