K093143 is an FDA 510(k) clearance for the MISSION BREATH ALCOHOL DETECTOR. This device is classified as a Devices, Breath Trapping, Alcohol (Class I - General Controls, product code DJZ).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 28, 2010, 115 days after receiving the submission on October 5, 2009.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3050.
| 510(k) Number | K093143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2009 |
| Decision Date | January 28, 2010 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJZ — Devices, Breath Trapping, Alcohol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3050 |