K923510 is an FDA 510(k) clearance for the ALT (GPT) - ALANINE AMINOTRANSFERASE. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on November 16, 1992, 124 days after receiving the submission on July 15, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K923510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1992 |
| Decision Date | November 16, 1992 |
| 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 |