K861775 is an FDA 510(k) clearance for the TWIN BUN/GLUCOSE. This device is classified as a Diacetyl-monoxime, Urea Nitrogen (Class II - Special Controls, product code CDW).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 27, 1986, 50 days after receiving the submission on May 8, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K861775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1986 |
| Decision Date | June 27, 1986 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDW — Diacetyl-monoxime, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |