K772082 is an FDA 510(k) clearance for the ENZAC URIC ACID 100-TEST KIT. This device is classified as a Acid, Uric, Phosphotungstate Reduction (Class I - General Controls, product code CDH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 28, 1977, 25 days after receiving the submission on November 3, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K772082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1977 |
| Decision Date | November 28, 1977 |
| Days to Decision | 25 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 |