K780634 is an FDA 510(k) clearance for the SINGLE VIAL 10 SGOT-TRIS. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II - Special Controls, product code CIT).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on May 18, 1978, 31 days after receiving the submission on April 17, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K780634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1978 |
| Decision Date | May 18, 1978 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | CIT — Nadh Oxidation/nad Reduction, Ast/sgot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1100 |