K792545 is an FDA 510(k) clearance for the URIC ACID KIT. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I - General Controls, product code KNK).
Submitted by Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1980, 50 days after receiving the submission on December 10, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K792545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1979 |
| Decision Date | January 29, 1980 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KNK — Acid, Uric, Uricase (colorimetric) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |