K971133 is an FDA 510(k) clearance for the URIC, UA, OR URIC ACID. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I - General Controls, product code KNK).
Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on April 14, 1997, 18 days after receiving the submission on March 27, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K971133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1997 |
| Decision Date | April 14, 1997 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KNK — Acid, Uric, Uricase (colorimetric) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |