Device Classification Name |
system, test, automated blood grouping and antibody
|
510(k) Number |
BK190320 |
Tradename |
DG Reader
|
Device Name |
System, Test, Automated Blood Grouping and Antibody |
Original Applicant |
Diagnostic Grifols, S. A. |
passeig fluvial, 24 |
barcelona |
parets del valles,
08150,
SPAIN
|
|
Regulation Number | 864.9175
|
Classification Product Code |
|
Date Received | 02/12/2019 |
Decision Date | 12/10/2019 |
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 |
Yes
|
|
|