K760430 is an FDA 510(k) clearance for the BUN-REATIVE. This device is classified as a Electrode, Ion Specific, Urea Nitrogen (Class II - Special Controls, product code CDS).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1976, 80 days after receiving the submission on August 13, 1976.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K760430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1976 |
| Decision Date | November 01, 1976 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDS — Electrode, Ion Specific, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |