510(k) K901276

HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL by Diagnostic Products Corp. — Product Code DIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1990
Date Received
March 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type