K211973 is an FDA 510(k) clearance for the DRI Cocaine Metabolite Assay. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on September 24, 2021, 91 days after receiving the submission on June 25, 2021.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K211973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2021 |
| Decision Date | September 24, 2021 |
| Days to Decision | 91 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 |