K201228 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair. This device is classified as a Enzyme Immunoassay, Cocaine (Class II - Special Controls, product code JXO).
Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on June 25, 2021, 414 days after receiving the submission on May 7, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K201228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2020 |
| Decision Date | June 25, 2021 |
| Days to Decision | 414 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXO - Enzyme Immunoassay, Cocaine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |