K151986

Substantially Equivalent

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.
Product code: CDZ
Advisory panel: Clinical Chemistry
Date received: 2015-07-17
Decision date: 2016-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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