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510(k) K142044

CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE by Guangzhou Wondfo Biotech Co., Ltd. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2014
Date Received
July 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

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