K810390 is an FDA 510(k) clearance for the AST (UV) TEST. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II - Special Controls, product code CIT).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1981, 13 days after receiving the submission on February 10, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K810390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1981 |
| Decision Date | February 23, 1981 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIT — Nadh Oxidation/nad Reduction, Ast/sgot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1100 |