FDA 510(k) Premarket Notification K121987: WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST

Submission Details & Decision

Normalized public record details for 510(k) notification K121987.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K121987

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST

Product Code

DKZ

Decision Date

2012-08-01

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2012-07-06

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