K860465 is an FDA 510(k) clearance for the VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II - Special Controls, product code CIT).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 5, 1986, 88 days after receiving the submission on February 6, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K860465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1986 |
| Decision Date | May 05, 1986 |
| Days to Decision | 88 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 |