AMICUS Separator System

Separator, Automated, Blood Cell And Plasma, Therapeutic

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Amicus Separator System.

Pre-market Notification Details

Device IDK192150
501k NumberK192150
Device Name:AMICUS Separator System
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant Fresenius Kabi AG Bad Homburg,  DE 61346
ContactAunica Jones
CorrespondentAunica Jones
Fenwal, Inc. Three Corporate Drive Lake Zurich,  IL  60047
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2019-11-13

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