K010960 is an FDA 510(k) clearance for the EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229. This device is classified as a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II - Special Controls, product code DIC).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 26, 2001, 27 days after receiving the submission on March 30, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K010960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2001 |
| Decision Date | April 26, 2001 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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 |