K890743 is an FDA 510(k) clearance for the AD X(TM) ETHANOL. This device is classified as a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II - Special Controls, product code DIC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989, 193 days after receiving the submission on February 13, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K890743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1989 |
| Decision Date | August 25, 1989 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3040 |