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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK190333
Tradename TOMEs
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215
Regulation Number864.9165
Classification Product Code
MMH  
Date Received03/22/2019
Decision Date 12/03/2019
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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