|
Device |
system, test, automated blood grouping and antibody |
Product Code | KSZ |
Regulation Number |
864.9175
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO RAD MEDICAL DIAGNOSTICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIO-RAD MEDICAL DIAGNOSTICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
DIAGNOSTIC GRIFOLS, S. A. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
1. BK190318 System, Test, Automated Blood Grouping and Antibod ...
|
2. BK190320 System, Test, Automated Blood Grouping and Antibod ...
|
3. BK190321 System, Test, Automated Blood Grouping and Antibod ...
|
4. BK190379 System, Test, Automated Blood Grouping and Antibod ...
|
5. BK200467 System, Test, Automated Blood Grouping and Antibod ...
|
6. BK220738 System, Test, Automated Blood Grouping and Antibod ...
|
7. BK220751 System, Test, Automated Blood Grouping and Antibod ...
|
8. BK220752 System, Test, Automated Blood Grouping and Antibod ...
|
9. BK220753 System, Test, Automated Blood Grouping and Antibod ...
|
10. BK220754 System, Test, Automated Blood Grouping and Antibod ...
|
11. BK230820 System, Test, Automated Blood Grouping and Antibod ...
|
IMMUCOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
MICRO TYPING SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO-CLINICAL DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
STRATEC BIOMEDICAL UK LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|