|
Device |
single (specified) analyte controls (assayed and unassayed) |
Product Code | JJX |
Regulation Number |
862.1660
|
Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
AALTO SCIENTIFIC LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
AALTO SCIENTIFIC, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K143571 Audit MicroControls Linearity LQ Cystatin-C
|
2. K161874 Audit MicroControls Linearity DROP LQ Blood Glucos ...
|
ACON LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
APEX BIO TECHNOLOGY CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYER HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-RAD LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONIME CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
CLINIQA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONE BIOPRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIASORIN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIAZYME LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIREBIO DIAGNOSTICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FUJIREBIO DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IMMUNODIAGNOSTIC SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MAINE STANDARDS CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAINE STANDARDS COMPANY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROGENICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTIMETRIX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QUANTIMETRIX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RANDOX LABORATORIES, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ROCHE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
33
|
ROCHE DIAGNOSTICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ROCHE DIAGNOSTICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
SIEMENS HELATHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHNOPATH MANUFACTURING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSOH BIOSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|