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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 BK000039
Tradename Amicus Separator, Concurrent Collection of Red Blood Cells
Device Name Automated Blood Cell Separator -Filtration
Original Applicant
Fenwal Inc
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9245
Classification Product Code
GKT  
Date Received09/22/2000
Decision Date 08/26/2002
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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