THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY

Enzyme Immunoassay, Cannabinoids

MICROGENICS CORP.

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

Pre-market Notification Details

Device IDK101744
510k NumberK101744
Device Name:THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
ContactLisa Charter
CorrespondentLisa Charter
MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
Product CodeLDJ  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-22
Decision Date2011-04-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883005747 K101744 000
00884883005730 K101744 000
00884883005723 K101744 000
00884883000858 K101744 000
00884883000216 K101744 000

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