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510(k) K112236

WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST by Guangzhou Wondfo Biotech Co., Ltd. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2011
Date Received
August 4, 2011
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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