WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)

Enzyme Immunoassay, Amphetamine

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 Amphetamine Urine Test (amp 300), Wondfo Methamphetamine Urine Test (met 500).

Pre-market Notification Details

Device IDK122961
510k NumberK122961
Device Name:WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
ClassificationEnzyme Immunoassay, Amphetamine
Applicant Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg,  MD  20877
ContactJoe Shia
CorrespondentJoe Shia
Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg,  MD  20877
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-25
Decision Date2012-12-21
Summary:summary

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