FDA 510(k), K151986, 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

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
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Device Classification Name: radioimmunoassay, testosterones and dihydrotestosterone
Regulation Number: 862.1680
Classification Product Code: CDZ
Date Received: 07/17/2015
Decision Date: 06/29/2016
Regulation Medical Specialty: Clinical Chemistry

Total pages: 1741
Fully redacted pages: 712
Content pages: 1029