K922108 is an FDA 510(k) clearance for the KING DIAGNOSTICS AST (GOT) REAGENT. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II - Special Controls, product code CIT).
Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 15, 1992, 71 days after receiving the submission on May 5, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K922108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1992 |
| Decision Date | July 15, 1992 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIT — Nadh Oxidation/nad Reduction, Ast/sgot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1100 |