HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS

Assay, Heparin

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Liquid Heparin, Heparin Calibrators And Lmw And Uf Heparin Controls.

Pre-market Notification Details

Device IDK090209
510k NumberK090209
Device Name:HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
ClassificationAssay, Heparin
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeKFF  
Subsequent Product CodeGGN
Subsequent Product CodeJIS
CFR Regulation Number864.7525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-28
Decision Date2009-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950478683 K090209 000
08426950472483 K090209 000
08426950472476 K090209 000
08426950580324 K090209 000

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