IL TEST PLASMINOGEN

Test, Qualitative And Quantitative Factor Deficiency

INSTRUMENTATION LABORATORY CO.

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

Pre-market Notification Details

Device IDK981200
510k NumberK981200
Device Name:IL TEST PLASMINOGEN
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-02
Decision Date1998-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950078975 K981200 000

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