CEDIA DAU BARBITURATE ASSAY

Enzyme Immunoassay, Barbiturate

MICROGENICS CORP.

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

Pre-market Notification Details

Device IDK945344
510k NumberK945344
Device Name:CEDIA DAU BARBITURATE ASSAY
ClassificationEnzyme Immunoassay, Barbiturate
Applicant MICROGENICS CORP. 2380A BISSO LN. Concord,  CA  94520
ContactMary Koning
CorrespondentMary Koning
MICROGENICS CORP. 2380A BISSO LN. Concord,  CA  94520
Product CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-01
Decision Date1994-12-28

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