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ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191533
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2019
Days to Decision
79 days
Submission Type
Summary

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191533
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2019
Days to Decision
79 days
Submission Type
Summary