K860154 is an FDA 510(k) clearance for the BUN (ENZYMATIC BERTHELOT) REAGENT SET. This device is classified as a Berthelot Indophenol, Urea Nitrogen (Class II - Special Controls, product code CDL).
Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 6, 1986, 21 days after receiving the submission on January 16, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K860154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1986 |
| Decision Date | February 06, 1986 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDL — Berthelot Indophenol, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |