K142353 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on October 7, 2014, 47 days after receiving the submission on August 21, 2014.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K142353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2014 |
| Decision Date | October 07, 2014 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |