THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY

Enzyme Immunoassay, Amphetamine

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Dri Amphetamines Assay.

Pre-market Notification Details

Device IDK093114
510k NumberK093114
Device Name:THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
ClassificationEnzyme Immunoassay, Amphetamine
Applicant MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
ContactHewuan Takkele
CorrespondentHewuan Takkele
MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-01
Decision Date2010-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740172329 K093114 000
00380740005566 K093114 000

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