FDA 510(k) Premarket Notification K161214: Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

Submission Details & Decision

Normalized public record details for 510(k) notification K161214.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K161214

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

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

Product Code

DIO

Decision Date

2016-06-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2016-04-29

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