K871645 is an FDA 510(k) clearance for the TDXR REA(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 June 11, 1987, 44 days after receiving the submission on April 28, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K871645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1987 |
| Decision Date | June 11, 1987 |
| Days to Decision | 44 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 |