|
Device |
system, test, vitamin d |
Product Code | MRG |
Regulation Number |
862.1825
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIO-RAD LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOKIT S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIASOURCE IMMUNOASSAYS, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIAZYME LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
1. K102432 DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688 ...
|
2. K122420 DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HY ...
|
3. K133410 DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAM ...
|
4. K172992 Diazyme EZ Vitamin D Assay
|
EUROIMMUN US |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIREBIO DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMMUNODIAGNOSTIC SYSTEMS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMMUNODIAGNOSTIC SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IMMUNODIAGNOSTIC SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMMUNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOENTEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO-CLINICAL DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUALIGEN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROCHE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIEMENS HEALTHCARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TOSOH BIOSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|