LZI Cotinine II Enzyme Immunoassay

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Cotinine Ii Enzyme Immunoassay.

Pre-market Notification Details

Device IDK192299
501k NumberK192299
Device Name:LZI Cotinine II Enzyme Immunoassay
ClassificationEnzyme Immunoassay, Nicotine And Nicotine Metabolites
Applicant Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara,  CA  95051
ContactBernice Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara,  CA  95051
Product CodeMKU  
CFR Regulation Number862.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyToxicology
501k Review PanelToxicology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2019-11-21

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