HemosIL D-Dimer HS

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil D-dimer Hs.

Pre-market Notification Details

Device IDK151534
510k NumberK151534
Device Name:HemosIL D-Dimer HS
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road Bedford,  MA  01730
ContactNikita Malladi
CorrespondentNikita Malladi
INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road Bedford,  MA  01730
Product CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-08
Decision Date2015-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950358695 K151534 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.