The following data is part of a premarket notification filed by Psychemedics Corporation with the FDA for Psychemedics Homogeneous Enzyme Immunoassay For Amphetamines In Hair.
| Device ID | K210212 |
| 510k Number | K210212 |
| Device Name: | Psychemedics Homogeneous Enzyme Immunoassay For Amphetamines In Hair |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-27 |
| Decision Date | 2021-12-15 |