VWF-IX:AG CONTROL PLASMA

Test, Qualitative And Quantitative Factor Deficiency

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Vwf-ix:ag Control Plasma.

Pre-market Notification Details

Device IDK861217
510k NumberK861217
Device Name:VWF-IX:AG CONTROL PLASMA
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
ContactLoc B Le
CorrespondentLoc B Le
AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-31
Decision Date1986-05-20

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