The following data is part of a premarket notification filed by Psychemedics Corporation with the FDA for Psychemedics Homogeneous Enzyme Immunoassay For Cocaine In Hair.
| Device ID | K201228 |
| 510k Number | K201228 |
| Device Name: | Psychemedics Homogeneous Enzyme Immunoassay For Cocaine In Hair |
| Classification | Enzyme Immunoassay, Cocaine |
| Applicant | Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 |
| Contact | Neil Stowe |
| Correspondent | Neil Stowe Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 |
| Product Code | JXO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-07 |
| Decision Date | 2021-06-25 |