Device Classification Name |
separator, automated, blood cell, diagnostic
|
510(k) Number |
BK200498 |
Tradename |
NexSys PCS Plasma Collection System with Persona Technology
|
Device Name |
Automated Blood Cell Separators |
Original Applicant |
Haemonetics Corporation |
125 summer st |
boston,
MA
02110
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 07/02/2020 |
Decision Date | 10/02/2020 |
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
|
|
|