FDA 510(k) Premarket Notification K112310: WONDFO METHADONE URINE TEST,OPIATE TEST

Submission Details & Decision

Normalized public record details for 510(k) notification K112310.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K112310

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

WONDFO METHADONE URINE TEST,OPIATE TEST

Product Code

DJG

Decision Date

2011-09-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2011-08-10

Related Establishments / Registrations

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