K941314 is an FDA 510(k) clearance for the STANBIO ALT/GPT (LUQUI-UV) TEST SET. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on July 20, 1994, 124 days after receiving the submission on March 18, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K941314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1994 |
| Decision Date | July 20, 1994 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |