Last synced on 24 March 2023 at 11:04 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151986
510(k) Type
Traditional
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/29/2016
Days to Decision
348 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151986
510(k) Type
Traditional
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/29/2016
Days to Decision
348 days
Submission Type
Summary