FDA 510(k) Premarket Notification K131232: WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)

Submission Details & Decision

Normalized public record details for 510(k) notification K131232.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K131232

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)

Product Code

DJR

Decision Date

2013-05-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2013-05-01

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