HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

Reagent, Russel Viper Venom

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Drvvt Screen & Hemosil Drvvt Confirm.

Pre-market Notification Details

Device IDK110031
510k NumberK110031
Device Name:HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
ClassificationReagent, Russel Viper Venom
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactJacqueline Emery
CorrespondentJacqueline Emery
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGIR  
CFR Regulation Number864.8950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-05
Decision Date2011-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950513711 K110031 000
08426950513704 K110031 000

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