HEMOSIL ANTITHROMBIN

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 Antithrombin.

Pre-market Notification Details

Device IDK070301
510k NumberK070301
Device Name:HEMOSIL ANTITHROMBIN
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 Received2007-01-31
Decision Date2007-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950062325 K070301 000

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