K192517 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Cotinine in Hair. This device is classified as a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I - General Controls, product code MKU).
Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on April 22, 2020, 222 days after receiving the submission on September 13, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3220.
| 510(k) Number | K192517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2019 |
| Decision Date | April 22, 2020 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MKU - Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3220 |