K952839 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY. This device is classified as a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II - Special Controls, product code DML).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 24, 1995, 64 days after receiving the submission on June 21, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K952839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1995 |
| Decision Date | August 24, 1995 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DML — Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3040 |