COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA

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 Coagulation Factor Viii Deficient Substrate Plasma.

Pre-market Notification Details

Device IDK853462
510k NumberK853462
Device Name:COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN DADE P.O. BOX 25101 Santa Ana,  CA  92799
ContactJames E Keller
CorrespondentJames E Keller
AMERICAN DADE P.O. BOX 25101 Santa Ana,  CA  92799
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-19
Decision Date1985-08-29

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