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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 BK080035
Tradenames COBE Spectra Apheresis System, Trima Accel Automated Blood Component Collection 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 Received07/31/2008
Decision Date 08/29/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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