K800190 is an FDA 510(k) clearance for the STANBIO DIRECT URIC ACID TEST SET #0770. This device is classified as a Acid, Uric, Phosphotungstate Reduction (Class I - General Controls, product code CDH).
Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980, 15 days after receiving the submission on January 29, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K800190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1980 |
| Decision Date | February 13, 1980 |
| 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 |