|
Device |
system, test, human chorionic gonadotropin |
Product Code | DHA |
Regulation Number |
862.1155
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K170317 Alinity i Total ß-hCG Reagent Kit, Alinity i Syste ...
|
2. K230790 Alinity i Total B-hCG Reagent Kit, Alinity c Gluco ...
|
3. K230937 Alinity i Total ß-hCG Reagent Kit, GLP systems Tra ...
|
ABBOTT POINT OF CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIAZYME LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIAZYME LABORATORIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU WONDFO BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO CLINICAL DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROCHE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YHLO BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|