The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Microplate Eia For Amphetamine.
| Device ID | K130811 |
| 510k Number | K130811 |
| Device Name: | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
| Contact | Virginia Hill |
| Correspondent | Virginia Hill PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-05-02 |
| Summary: | summary |