HEMOSIL PT-FIBRINOGEN HS PLUS

Test, Time, Prothrombin

INSTRUMENTATION LABORATORY CO.

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

Pre-market Notification Details

Device IDK060931
510k NumberK060931
Device Name:HEMOSIL PT-FIBRINOGEN HS PLUS
ClassificationTest, Time, Prothrombin
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-05
Decision Date2006-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950058403 K060931 000

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