PROTOPATH FACTOR IX ASSAY

Test, Qualitative And Quantitative Factor Deficiency

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Protopath Factor Ix Assay.

Pre-market Notification Details

Device IDK834050
510k NumberK834050
Device Name:PROTOPATH FACTOR IX ASSAY
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN DADE 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-23
Decision Date1984-02-04

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