K-numberK161214
Device nameWondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Product codeDIO
Device classClass II
Decision dateJun 27, 2016
DecisionSubstantially Equivalent
Regulation862.3250
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