K032461 is an FDA 510(k) clearance for the ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221. This device is classified as a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II - Special Controls, product code DIC).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on October 3, 2003, 53 days after receiving the submission on August 11, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K032461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2003 |
| Decision Date | October 03, 2003 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| 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 |