K780859 is an FDA 510(k) clearance for the PRINCETON BIOMEDIX URICASE (UV). This device is classified as a Acid, Uric, Uricase (u.v.) (Class I - General Controls, product code CDO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 27, 1978, 64 days after receiving the submission on May 24, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.
| 510(k) Number | K780859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1978 |
| Decision Date | July 27, 1978 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDO — Acid, Uric, Uricase (u.v.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |