CEDIA DAU OPIATE ASSAY

Enzyme Immunoassay, Opiates

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Opiate Assay.

Pre-market Notification Details

Device IDK941195
510k NumberK941195
Device Name:CEDIA DAU OPIATE ASSAY
ClassificationEnzyme Immunoassay, Opiates
Applicant MICROGENICS CORP. 2380A BISSO LN. Concord,  CA  94520
ContactBetsy Soares-maddox
CorrespondentBetsy Soares-maddox
MICROGENICS CORP. 2380A BISSO LN. Concord,  CA  94520
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-14
Decision Date1994-09-07

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