K813342 is an FDA 510(k) clearance for the GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION. This device is classified as a Solution, Stabilized Enzyme (Class II - Special Controls, product code KSK).
Submitted by Gamma Biologicals, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1982, 99 days after receiving the submission on November 25, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.9400.
| 510(k) Number | K813342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1981 |
| Decision Date | March 04, 1982 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KSK — Solution, Stabilized Enzyme |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9400 |