The following data is part of a premarket notification filed by Psychemedics Corporation with the FDA for Psychemedics Microplate Eia For Cotinine In Hair.
| Device ID | K192517 |
| 510k Number | K192517 |
| Device Name: | Psychemedics Microplate EIA For Cotinine In Hair |
| Classification | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| 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 | MKU |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-13 |
| Decision Date | 2020-04-22 |