Solution, Stabilized Enzyme
FDA product code KSK · Class II (moderate risk) · 21 CFR 864.9400 · Hematology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | Gamma Biologicals, Inc. | 03/04/1982SE |
| K813404 | Freeze Dried FicinKSK · Traditional | Biological Corp. of America | 02/10/1982SE |
| K810803 | Freeze Dried PapainKSK · Traditional | Biological Corp. of America | 07/21/1981SE |
| K780962 | Automated EnzymeKSK · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 07/27/1978SE |
| K760123 | AutozymeKSK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1976SE |