ACL AcuStar

System, Multipurpose For In Vitro Coagulation Studies

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Acustar.

Pre-market Notification Details

Device IDK170314
510k NumberK170314
Device Name:ACL AcuStar
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactNikita Malladi
CorrespondentNikita Malladi
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-01
Decision Date2017-03-03
Summary:summary

Trademark Results [ACL AcuStar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACL ACUSTAR
ACL ACUSTAR
77097938 3781511 Live/Registered
Instrumentation Laboratory Company
2007-02-02

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