Device Classification Name |
blood establishment computer software and accessories
|
510(k) Number |
BK200517 |
Tradename |
GDS (Grifols Donation System)
|
Device Name |
Blood Establishment Computer Software and Accessories |
Original Applicant |
Biomat USA, Inc. |
2410 lillyvale ave |
los angeles,
CA
90032
|
|
Regulation Number | 864.9165
|
Classification Product Code |
|
Date Received | 08/17/2020 |
Decision Date | 11/05/2020 |
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
|