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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK110061
Tradename RegenKit-BCT Family Kits
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
RegenLab SA
en budron b2
ch-1052 le mont sur lausanne
Regulation Number864.9245
Classification Product Code
ORG  
Date Received10/27/2011
Decision Date 05/08/2012
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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