Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

Enzyme Immunoassay, Opiates

Co-Innovation Biotech Co., Ltd

The following data is part of a premarket notification filed by Co-innovation Biotech Co., Ltd with the FDA for Rapid Single/multi-drug Test Cup, Rapid Single/multi-drug Test Dipcard.

Pre-market Notification Details

Device IDK153050
510k NumberK153050
Device Name:Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
ClassificationEnzyme Immunoassay, Opiates
Applicant Co-Innovation Biotech Co., Ltd No. 13, Yanyuan Road, Tianhe District, Guangzhou,  CN
ContactHong Feng
CorrespondentHong Feng
Co-Innovation Biotech Co., Ltd No. 13, Yanyuan Road, Tianhe District, Guangzhou,  CN 510507
Product CodeDJG  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJC
Subsequent Product CodeDJR
Subsequent Product CodeDKZ
Subsequent Product CodeDNK
Subsequent Product CodeJXM
Subsequent Product CodeJXN
Subsequent Product CodeLAF
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
Subsequent Product CodeLFG
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-20
Decision Date2016-04-26
Summary:summary

NIH GUDID Devices

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