DRI Cocaine Metabolite Assay

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Microgenics Corporation

The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Dri Cocaine Metabolite Assay.

Pre-market Notification Details

Device IDK211973
510k NumberK211973
Device Name:DRI Cocaine Metabolite Assay
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant Microgenics Corporation 46500 Kato Road Fremont,  CA  94538
ContactNikhita Tandon
CorrespondentNikhita Tandon
Microgenics Corporation 46500 Kato Road Fremont,  CA  94538
Product CodeDIO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-25
Decision Date2021-09-24

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