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510(k) K022501

INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST by Alfa Scientific Designs, Inc. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2002
Date Received
July 29, 2002
Clearance Type
Abbreviated
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

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