|
Device |
radioimmunoassay, testosterones and dihydrotestosterone |
Product Code | CDZ |
Regulation Number |
862.1680
|
Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECKMAN COULTER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOKIT, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMMUNODIAGNOSTIC SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMMUNOTECH S.R.O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MONOBIND INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOENTEK USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUALIGEN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROCHE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROCHE DIAGNOSTICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K133491 ADVIA CENTAUR TESTOSTERONE (TSTO)
|
2. K151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur ...
|
3. K191533 ADVIA Centaur Testosterone II (TSTII), ADVIA Centa ...
|
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K133491 ADVIA CENTAUR TESTOSTERONE (TSTO)
|
2. K151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur ...
|
3. K191533 ADVIA Centaur Testosterone II (TSTII), ADVIA Centa ...
|
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSOH BIOSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|