The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Ria Methamphetamine And Mdma Assay.
| Device ID | K011185 |
| 510k Number | K011185 |
| Device Name: | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
| Contact | William R Tistle |
| Correspondent | William R Tistle PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
| Product Code | DJC |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-18 |
| Decision Date | 2002-01-24 |