SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

SAFECARE BIOTECH (HANGZHOU)CO.,LTD.

The following data is part of a premarket notification filed by Safecare Biotech (hangzhou)co.,ltd. with the FDA for Safecare Urine Test Amphetamine, Safecare Urine Test Cocaine, Safecare Urine Test Marijuana.

Pre-market Notification Details

Device IDK153646
510k NumberK153646
Device Name:SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant SAFECARE BIOTECH (HANGZHOU)CO.,LTD. BUILDING 2/203 NO.18 HAISHU RD., CANGQIAN SUB-DISTRICT, YUHANG DISTRICT Hangzhou,  CN 311121
ContactAlex Qiu
CorrespondentJoe Shia
LSI INTERNATIONAL 504 E DIAMOND AVE SUITE.I Gaithersburg,  MD  20877
Product CodeDIO  
Subsequent Product CodeDKZ
Subsequent Product CodeLDJ
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-03-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06974246460802 K153646 000
06974246460857 K153646 000

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