CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE

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 Cr3 Keyless Split Sample Cup Amphetamine-cocaine.

Pre-market Notification Details

Device IDK141532
510k NumberK141532
Device Name:CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
ClassificationEnzyme Immunoassay, Amphetamine
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 CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-10
Decision Date2014-07-14
Summary:summary

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