CANNABINOIDS URINE TEST

Enzyme Immunoassay, Cannabinoids

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 Cannabinoids Urine Test.

Pre-market Notification Details

Device IDK110182
510k NumberK110182
Device Name:CANNABINOIDS URINE TEST
ClassificationEnzyme Immunoassay, Cannabinoids
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 CodeLDJ  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-21
Decision Date2011-05-20
Summary:summary

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