K813404 is an FDA 510(k) clearance for the FREEZE DRIED FICIN. This device is classified as a Solution, Stabilized Enzyme (Class II - Special Controls, product code KSK).
Submitted by Biological Corp. of America (Mchenry, US). The FDA issued a Cleared decision on February 10, 1982, 65 days after receiving the submission on December 7, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.9400.
| 510(k) Number | K813404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1981 |
| Decision Date | February 10, 1982 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KSK — Solution, Stabilized Enzyme |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9400 |