K191638 is an FDA 510(k) clearance for the Pointe Scientific Cocaine Metabolite Enzyme Immunoassay. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Medtest DX (Lincoln Park, US). The FDA issued a Cleared decision on March 12, 2020, 267 days after receiving the submission on June 19, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K191638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2019 |
| Decision Date | March 12, 2020 |
| Days to Decision | 267 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 |