K792328 is an FDA 510(k) clearance for the STATTEK BUN. This device is classified as a Urease, Photometric, Urea Nitrogen (Class II - Special Controls, product code CDN).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on December 18, 1979, 29 days after receiving the submission on November 19, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K792328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1979 |
| Decision Date | December 18, 1979 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDN — Urease, Photometric, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |