DRI Hydrocodone Assay

Enzyme Immunoassay, Opiates

Microgenics Corporation

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

Pre-market Notification Details

Device IDK173195
510k NumberK173195
Device Name:DRI Hydrocodone Assay
ClassificationEnzyme Immunoassay, Opiates
Applicant Microgenics Corporation 46500 Kato Road Fremont,  CA  94538
ContactMinoti Patel
CorrespondentMinoti Patel
Microgenics Corporation 46500 Kato Road Fremont,  CA  94538
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-02
Decision Date2018-02-13
Summary:summary

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