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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 BK120041
Tradenames ALYX Component Collection System, AMICUS Separator System
Device Name Automated Blood Cell Separators
Original Applicant
Fenwal, Inc.
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9245
Classification Product Code
GKT  
Date Received07/12/2012
Decision Date 10/03/2012
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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