K820466 is an FDA 510(k) clearance for the SGOT REAGENT SET. This device is classified as a Diazo, Ast/sgot (Class II - Special Controls, product code CIQ).
Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1982, 17 days after receiving the submission on February 22, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K820466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1982 |
| Decision Date | March 11, 1982 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIQ — Diazo, Ast/sgot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1100 |