HemosIL Von Willebrand Factor Antigen

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 Factor Antigen.

Pre-market Notification Details

Device IDK200033
510k NumberK200033
Device Name:HemosIL Von Willebrand Factor Antigen
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactNikita Malladi
CorrespondentNikita Malladi
Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-07
Decision Date2020-08-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000
08426950041177 K200033 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.