Device Classification Name |
platelet and plasma separator for bone graft handling
|
510(k) Number |
BK120066 |
Tradenames |
RegenKit-ATS-3,
RegenKit-BCT-1 Plus,
RegenKit-BCT-2 Plus
|
Device Name |
Platelet And Plasma Separator For Bone Graft Handling |
Original Applicant |
RegenLab SA |
3428 avenue marcil |
montreal,
Quebec,
H4A 2Z3,
CANADA
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 11/02/2012 |
Decision Date | 02/05/2014 |
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
|
|
|