HEMOSIL VON WILLEBRAND ACTIVITY

Test, Qualitative And Quantitative Factor Deficiency

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Von Willebrand Activity.

Pre-market Notification Details

Device IDK040843
510k NumberK040843
Device Name:HEMOSIL VON WILLEBRAND ACTIVITY
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-01
Decision Date2004-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950078951 K040843 000

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