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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 K083844
Device Name ADVIA CENTAUR TSH3-ULTRA METHOD
Applicant
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Applicant Contact Ernest Joseph
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact Ernest Joseph
Regulation Number862.1690
Classification Product Code
JLW  
Date Received12/24/2008
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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