ABBOTT PHENOBARBITAL ASSAY

Enzyme Immunoassay, Phenobarbital

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Abbott Phenobarbital Assay.

Pre-market Notification Details

Device IDK123271
510k NumberK123271
Device Name:ABBOTT PHENOBARBITAL ASSAY
ClassificationEnzyme Immunoassay, Phenobarbital
Applicant MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
ContactKaren Lee
CorrespondentKaren Lee
MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
Product CodeDLZ  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-19
Decision Date2013-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740154110 K123271 000
00380740102692 K123271 000

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