K812978 is an FDA 510(k) clearance for the URIC ACID SYSTEM PACK TEST. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I - General Controls, product code KNK).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981, 14 days after receiving the submission on October 23, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K812978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1981 |
| Decision Date | November 06, 1981 |
| Days to Decision | 14 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 |