510(k) K011426

PSYCHEMEDICS RIA CANNABINOID ASSAY by Psychemedics Corp. — Product Code LAT

K011426 is an FDA 510(k) premarket notification submitted by Psychemedics Corp. for the device "PSYCHEMEDICS RIA CANNABINOID ASSAY". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code LAT (Radioimmunoassay, Cannabinoid(S)), a Class II device regulated under 21 CFR 862.3870. Psychemedics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
May 8, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cannabinoid(S)
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type