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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 BK190351
Tradenames ALYX 2RBC LR Kit, ALYX Component Collection System, ALYX RBC/Plasma Kit, ALYX Red Kit
Device Name Automated Blood Cell Separators
Original Applicant
Fresenius Kabi USA LLC.
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9245
Classification Product Code
GKT  
Date Received05/08/2019
Decision Date 06/06/2019
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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