K023184 is an FDA 510(k) clearance for the ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM. This device is classified as a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II - Special Controls, product code DIC).
Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 18, 2002, 55 days after receiving the submission on September 24, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K023184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2002 |
| Decision Date | November 18, 2002 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3040 |