IL TEST HEPARIN

Assay, Heparin

INSTRUMENTATION LABORATORY CO.

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

Pre-market Notification Details

Device IDK980242
510k NumberK980242
Device Name:IL TEST HEPARIN
ClassificationAssay, Heparin
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeKFF  
CFR Regulation Number864.7525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-23
Decision Date1998-03-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950472490 K980242 000
08426950042211 K980242 000

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