K965126 is an FDA 510(k) clearance for the AST/SGOT. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II - Special Controls, product code CIT).
Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on January 17, 1997, 25 days after receiving the submission on December 23, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K965126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1996 |
| Decision Date | January 17, 1997 |
| Days to Decision | 25 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 |