COATEST SP FVIII

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 Coatest Sp Fviii.

Pre-market Notification Details

Device IDK042576
510k NumberK042576
Device Name:COATEST SP FVIII
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-22
Decision Date2004-12-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950453000 K042576 000
08426950452997 K042576 000

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