K892395 is an FDA 510(k) clearance for the AMRESCO URIC ACID REAGENTS #7628. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK).
Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on May 24, 1989, 47 days after receiving the submission on April 7, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K892395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1989 |
| Decision Date | May 24, 1989 |
| Days to Decision | 47 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 |