K163590 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Benzodiazepines in Hair. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on September 15, 2017, 269 days after receiving the submission on December 20, 2016.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K163590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2016 |
| Decision Date | September 15, 2017 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXM - Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |