Device Classification Name |
separator, automated, blood cell, diagnostic
|
510(k) Number |
BK190351 |
Tradenames |
ALYX 2RBC LR Kit,
ALYX Component Collection System,
ALYX RBC/Plasma Kit,
ALYX Red Kit
|
Device Name |
Automated Blood Cell Separators |
Original Applicant |
Fresenius Kabi USA LLC. |
three corporate drive |
lake zurich,
IL
60047
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 05/08/2019 |
Decision Date | 06/06/2019 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Special
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|