K971967 is an FDA 510(k) clearance for the BUN. This device is classified as a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II - Special Controls, product code CDQ).
Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 17, 1997, 20 days after receiving the submission on May 28, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K971967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1997 |
| Decision Date | June 17, 1997 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |