K033278 is an FDA 510(k) clearance for the RANDOX URIC ACID. This device is classified as a Acid, Uric, Uricase (u.v.) (Class I - General Controls, product code CDO).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 27, 2004, 140 days after receiving the submission on October 10, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K033278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2003 |
| Decision Date | February 27, 2004 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CDO — Acid, Uric, Uricase (u.v.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |