510(k) K000851

PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR by Psychemedics Corp. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2000
Date Received
March 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type