ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS

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 Family 50 Series: Acl Top 350 Cts; Acl Top 550 Cts; Acl Top 750; Acl Top 750 Cts; Acl Top 750 Las.

Pre-market Notification Details

Device IDK150877
510k NumberK150877
Device Name:ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
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 Received2015-04-01
Decision Date2015-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950784067 K150877 000
08426950784050 K150877 000
08426950729242 K150877 000
08426950784081 K150877 000
08426950784074 K150877 000

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