ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)

Instrument, Coagulation, Automated

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top (with System Software V3.0.0).

Pre-market Notification Details

Device IDK073377
510k NumberK073377
Device Name:ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
ClassificationInstrument, Coagulation, Automated
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGKP  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-03
Decision Date2008-05-04
Summary:summary

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