MICROGENICS CYCLOSPORINE CONTROL KIT

Drug Specific Control Materials

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Microgenics Cyclosporine Control Kit.

Pre-market Notification Details

Device IDK032842
510k NumberK032842
Device Name:MICROGENICS CYCLOSPORINE CONTROL KIT
ClassificationDrug Specific Control Materials
Applicant MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
ContactDavid Casal
CorrespondentDavid Casal
MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
Product CodeLAS  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-11
Decision Date2003-10-17
Summary:summary

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