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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 K141999
Device Name ADVIA CENTAUR TSH
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact Alex Hsu
Correspondent
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact Alex Hsu
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JJE  
Date Received07/23/2014
Decision Date 04/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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