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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK200478
Tradename Aurora Xi Plasmapheresis System/Aurora Xi/Aurora Xi system/Aurora Xi
Device Name Automated Blood Cell Separators
Original Applicant
Fresenius Kabi AG
else-kroner-strasse 1
bad homburg,  61346,  GERMANY
Regulation Number864.9245
Classification Product Code
GKT  
Date Received04/10/2020
Decision Date 05/07/2020
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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