The following data is part of a premarket notification filed by Psychemedics Corporation with the FDA for Psychemedics Microplate Eia For Benzodiazepines In Hair.
| Device ID | K163590 |
| 510k Number | K163590 |
| Device Name: | Psychemedics Microplate EIA For Benzodiazepines In Hair |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 |
| Contact | Virginia Hill |
| Correspondent | Virginia Hill Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-20 |
| Decision Date | 2017-09-15 |
| Summary: | summary |