HEMOSIL FACTOR VIII DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Factor Viii Deficient Plasma.

Pre-market Notification Details

Device IDK034007
510k NumberK034007
Device Name:HEMOSIL FACTOR VIII DEFICIENT PLASMA
ClassificationPlasma, Coagulation Factor Deficient
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-24
Decision Date2004-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950478560 K034007 000

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