IL TEST VON WILLEBRAND FACTOR

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 Il Test Von Willebrand Factor.

Pre-market Notification Details

Device IDK992704
510k NumberK992704
Device Name:IL TEST VON WILLEBRAND FACTOR
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-12
Decision Date1999-11-01
Summary:summary

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