K812926 is an FDA 510(k) clearance for the ALT-QUANTICHROM. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 6, 1981, 18 days after receiving the submission on October 19, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K812926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1981 |
| Decision Date | November 06, 1981 |
| Days to Decision | 18 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 |