IL TEST LIQUID 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 Il Test Liquid Antithrombin.

Pre-market Notification Details

Device IDK994238
510k NumberK994238
Device Name:IL TEST LIQUID ANTITHROMBIN
ClassificationAntithrombin Iii Quantitation
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeJBQ  
CFR Regulation Number864.7060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-16
Decision Date2000-06-23
Summary:summary

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