Device Classification Name |
blood establishment computer software and accessories
|
510(k) Number |
BK230814 |
Tradename |
SmartDMS
|
Device Name |
Blood Establishment Computer Software and Accessories |
Original Applicant |
Life Plasma, Inc. |
5438 perkiomen ave |
reading,
PA
19606
|
|
Regulation Number | 864.9165
|
Classification Product Code |
|
Date Received | 06/12/2023 |
Decision Date | 04/16/2024 |
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
|
|
|