COAMATIC HEPARIN

Assay, Heparin

INSTRUMENTATION LABORATORY CO.

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

Pre-market Notification Details

Device IDK983178
510k NumberK983178
Device Name:COAMATIC HEPARIN
ClassificationAssay, Heparin
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeKFF  
CFR Regulation Number864.7525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-11
Decision Date1998-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950088967 K983178 000

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