K013538 is an FDA 510(k) clearance for the ETHANOL. This device is classified as a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II - Special Controls, product code DML).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on December 14, 2001, 51 days after receiving the submission on October 24, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K013538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2001 |
| Decision Date | December 14, 2001 |
| Days to Decision | 51 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 |