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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 BK090003
Tradename Trima Accel System
Device Name Automated Blood Cell Separators
Original Applicant
CaridianBCT
10811 w. collins avenue
lakewood,  CO  80215 4498
Regulation Number864.9245
Classification Product Code
GKT  
Date Received01/21/2009
Decision Date 02/16/2010
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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