K810803 is an FDA 510(k) clearance for the FREEZE DRIED PAPAIN. 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 July 21, 1981, 119 days after receiving the submission on March 24, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.9400.
| 510(k) Number | K810803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1981 |
| Decision Date | July 21, 1981 |
| Days to Decision | 119 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 |