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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K150403
Device Name ADVIA Centaur TSH3-Ultra
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10591
Applicant Contact MATTHEW GEE
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10591
Correspondent Contact MATTHEW GEE
Regulation Number862.1690
Classification Product Code
JLW  
Date Received02/18/2015
Decision Date 05/01/2015
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
Recalls CDRH Recalls
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