K810088 is an FDA 510(k) clearance for the URIC ACID (TPTZ) COLORINMETRIC. This device is classified as a Acid, Uric, Phosphotungstate Reduction (Class I - General Controls, product code CDH).
Submitted by Bio-Analytics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 15 days after receiving the submission on January 13, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K810088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1981 |
| Decision Date | January 28, 1981 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDH — Acid, Uric, Phosphotungstate Reduction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |