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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 BK241135
Tradename Aurora Xi Plasmapheresis System (6R4612, 6R4612R)
Device Name Automated Blood Cell Separators
Original Applicant
Fresenius Kabi AG
else-kroner-strasse 1
Bad Homburg,  61352,  GERMANY
Regulation Number864.9245
Classification Product Code
GKT  
Date Received10/28/2024
Decision Date 01/24/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
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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