K802371 is an FDA 510(k) clearance for the URIC ACID/ALDH. This device is classified as a Acid, Uric, Uricase (u.v.) (Class I - General Controls, product code CDO).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on October 23, 1980, 24 days after receiving the submission on September 29, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K802371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDO — Acid, Uric, Uricase (u.v.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |