Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)— 510(k) K161214

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K161214 for Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard), Substantially Equivalent on 2016-06-27. Applicant: Guangzhou Wondfo Biotech Co., Ltd..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 2016-04-29
Decision date: 2016-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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