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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, transfer (blood/plasma)
510(k) Number BK860012
Tradename Imugard Leukocyte Filter
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Terumo Corporation
2805 east ana street
compton,  CA  90221
Regulation Number864.9875
Classification Product Code
KSB  
Date Received01/06/1986
Decision Date 05/16/1990
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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