CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Test, Opiates, Over The Counter

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 Multi-drug Test Dip Card, Clungene Multi-drug Test Easy Cup.

Pre-market Notification Details

Device IDK181790
510k NumberK181790
Device Name:CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
ClassificationTest, Opiates, Over The Counter
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 CodeNGL  
Subsequent Product CodeNGG
Subsequent Product CodeNGM
Subsequent Product CodeQAW
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-05
Decision Date2018-07-26
Summary:summary

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