K800689 is an FDA 510(k) clearance for the REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Diagnostic Solutions, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980, 65 days after receiving the submission on March 26, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K800689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1980 |
| Decision Date | May 30, 1980 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |