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

Enzyme Immunoassay, Methadone

Guangzhou Wondfo Biotech Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Methadone Urine Test (mtd 200), Wondofo Morphine Urine Test (mop 100).

Pre-market Notification Details

Device IDK131232
510k NumberK131232
Device Name:WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
ClassificationEnzyme Immunoassay, Methadone
Applicant Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg,  MD  20878
ContactJoe Shia
CorrespondentJoe Shia
Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg,  MD  20878
Product CodeDJR  
CFR Regulation Number862.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-01
Decision Date2013-05-31
Summary:summary

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