Device Classification Name |
system, test, automated blood grouping and antibody
|
510(k) Number |
BK190312 |
Tradename |
TANGO infinity
|
Device Name |
System, Test, Automated Blood Grouping and Antibody |
Original Applicant |
Bio-Rad Medical Diagnostics GmbH |
industriestrasse 1 |
dreieich,
63303,
GERMANY
|
|
Regulation Number | 864.9175
|
Classification Product Code |
|
Date Received | 01/29/2019 |
Decision Date | 04/25/2019 |
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 |
Yes
|
|
|