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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 BK900005
Tradename Closed System Apheresis Kit- CS3000 Blood Cell Separator
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 Received01/10/1990
Decision Date 06/05/1990
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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