ASSERA-PLATE PROTEIN C KIT

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 Assera-plate Protein C Kit.

Pre-market Notification Details

Device IDK861475
510k NumberK861475
Device Name:ASSERA-PLATE PROTEIN C KIT
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
ContactLoc B Le,phd
CorrespondentLoc B Le,phd
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 Received1986-04-22
Decision Date1986-06-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.