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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K163658
Device Name ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Applicant Contact Darius Daruwala
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact Darius Daruwala
Regulation Number862.1545
Classification Product Code
CEW  
Date Received12/23/2016
Decision Date 05/23/2017
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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