WONDFO METHADONE URINE TEST,OPIATE TEST

Enzyme Immunoassay, Opiates

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,opiate Test.

Pre-market Notification Details

Device IDK112310
510k NumberK112310
Device Name:WONDFO METHADONE URINE TEST,OPIATE TEST
ClassificationEnzyme Immunoassay, Opiates
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 CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-10
Decision Date2011-09-08

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