FDA 510(k) Premarket Notification K133968: WONDFO MULTI-DRUG URINE TEST CUP, PANEL

Submission Details & Decision

Normalized public record details for 510(k) notification K133968.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K133968

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

WONDFO MULTI-DRUG URINE TEST CUP, PANEL

Product Code

DKZ

Decision Date

2014-02-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Special

Third Party Flag

Date Received

2013-12-26

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