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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, semi-automated, blood component
510(k) Number BK230838
Tradename IMUGARD WB PLT Platelet Pooling Set
Device Name Semi-automated Blood Component Separator
Original Applicant
TERUMO BCT
10810 w. collins ave
lakewood,  CO  80215
Classification Product Code
MYY  
Secondary Product Code
KSR 
Date Received04/28/2023
Decision Date 07/27/2023
Decision substantially equivalent (SE)
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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