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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK230825
Tradename ALYX 2RBC-LR Kit
Device Name Automated Blood Cell Separators
Original Applicant
Fresenius Kabi AG
else-kroner-strasse 1
bad homburg,  61346, 
Regulation Number864.9245
Classification Product Code
GKT  
Date Received03/27/2023
Decision Date 04/05/2024
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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