ACL 6000 SYSTEM (ACL 6000)

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 6000 System (acl 6000).

Pre-market Notification Details

Device IDK961991
510k NumberK961991
Device Name:ACL 6000 SYSTEM (ACL 6000)
ClassificationInstrument, Coagulation, Automated
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
ContactBetty J Lane
CorrespondentBetty J Lane
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeGKP  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-21
Decision Date1996-09-04

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