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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 BK140187
Tradenames Blade Arm Module, Genesis Rapid Weld STW, Weld Blade Module Replacement Kits
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
GenesisBPS, LLC
465 state route 17
ramsey,  NJ  07446
Regulation Number864.9875
Classification Product Code
KSB  
Date Received10/21/2014
Decision Date 03/06/2015
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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