K201326 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on July 27, 2021, 434 days after receiving the submission on May 19, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K201326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2020 |
| Decision Date | July 27, 2021 |
| Days to Decision | 434 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG - Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |