The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Ria Cannabinoid Assay.
Device ID | K011426 |
510k Number | K011426 |
Device Name: | PSYCHEMEDICS RIA CANNABINOID ASSAY |
Classification | Radioimmunoassay, Cannabinoid(s) |
Applicant | PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
Contact | William R Thistle |
Correspondent | William R Thistle PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
Product Code | LAT |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-08 |
Decision Date | 2002-05-03 |