HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS

System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Acustar Anti-b2 Glycoprotein-i; Igg, Igm, Igg Controls, Igm Controls.

Pre-market Notification Details

Device IDK091556
510k NumberK091556
Device Name:HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
ClassificationSystem,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeMSV  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-27
Decision Date2010-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426951289271 K091556 000
08426951289264 K091556 000
08426950497028 K091556 000
08426950497011 K091556 000
08426950496984 K091556 000
08426950496977 K091556 000
08426950594475 K091556 000
08426950594420 K091556 000

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