K932049 is an FDA 510(k) clearance for the STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II - Special Controls, product code CIT).
Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on November 16, 1993, 203 days after receiving the submission on April 27, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K932049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1993 |
| Decision Date | November 16, 1993 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIT — Nadh Oxidation/nad Reduction, Ast/sgot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1100 |