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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 BK170157
Tradename Trima Accel(R) Blood Collection System
Device Name Automated Blood Cell Separators
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215
Regulation Number864.9245
Classification Product Code
GKT  
Date Received12/11/2017
Decision Date 04/06/2018
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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