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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number862.1680
Classification Product Code
CDZ  
Subsequent Product Codes
JIT   JJX  
Date Received07/17/2015
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
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