Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K151986 |
Device Name |
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591 -5097
|
|
Applicant Contact |
MATTHEW GEE |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591 -5097
|
|
Correspondent Contact |
MATTHEW GEE |
Regulation Number | 862.1680
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/17/2015 |
Decision Date | 06/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|