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510(k) K023837

LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA by Princeton BioMeditech Corp. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2003
Date Received
November 18, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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