ACL TOP

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.

Pre-market Notification Details

Device IDK063679
510k NumberK063679
Device Name:ACL TOP
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-11
Decision Date2007-01-12
Summary:summary

Trademark Results [ACL TOP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACL TOP
ACL TOP
76426618 2792612 Live/Registered
Instrumentation Laboratory Company
2002-07-01

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