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510(k) K131754

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2013
Date Received
June 14, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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