510(k) K011185

PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY by Psychemedics Corp. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
April 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type