K903228 is an FDA 510(k) clearance for the EMIT ETS PLUS ETHYL ALCOHOL ASSAY. This device is classified as a Potassium Dichromate Specific Reagent For Alcohol (Class II - Special Controls, product code DMI).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 17, 1990, 25 days after receiving the submission on July 23, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3040.
| 510(k) Number | K903228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1990 |
| Decision Date | August 17, 1990 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DMI — Potassium Dichromate Specific Reagent For Alcohol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3040 |