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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 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
Reviewed by Third Party No
Expedited Review No
Combination Product No
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