KSK — Solution, Stabilized Enzyme Class II
FDA product code KSK covers "Solution, Stabilized Enzyme", a Class II medical device regulated under 21 CFR 864.9400. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSK
- Device Class
- Class II
- Regulation Number
- 864.9400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K813342 | gamma biologicals | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | March 4, 1982 |
| K813404 | biological corp. of america | FREEZE DRIED FICIN | February 10, 1982 |
| K810803 | biological corp. of america | FREEZE DRIED PAPAIN | July 21, 1981 |
| K780962 | hyland therapeutic div., travenol laboratories | AUTOMATED ENZYME | July 27, 1978 |
| K760123 | bd becton dickinson vacutainer systems preanalytic | AUTOZYME | July 20, 1976 |