HEMOSIL LIQUID ANTITHROMBIN XL

Antithrombin Iii Quantitation

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Liquid Antithrombin Xl.

Pre-market Notification Details

Device IDK033775
510k NumberK033775
Device Name:HEMOSIL LIQUID ANTITHROMBIN XL
ClassificationAntithrombin Iii Quantitation
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeJBQ  
CFR Regulation Number864.7060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-03
Decision Date2004-01-02
Summary:summary

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