CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

Enzyme Immunoassay, Amphetamine

Hangzhou Clongene Biotech Co., Ltd

The following data is part of a premarket notification filed by Hangzhou Clongene Biotech Co., Ltd with the FDA for Clungene Amphetamine Tests, Clungene Cocaine Tests, Clungene Oxazepam Tests.

Pre-market Notification Details

Device IDK161251
510k NumberK161251
Device Name:CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
ClassificationEnzyme Immunoassay, Amphetamine
Applicant Hangzhou Clongene Biotech Co., Ltd Building 4, No. 20 Longquan Road, Yuhang District Hangzhou,  CN 311121
ContactZheng Shujian
CorrespondentJesse Xia
LSI International 504 E Diamond Ave., Suite I Gaithersburg,  MD  20877
Product CodeDKZ  
Subsequent Product CodeDIO
Subsequent Product CodeJXM
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-03
Decision Date2016-08-30
Summary:summary

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