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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ferritin, antigen, antiserum, control
510(k) Number K171642
Device Name Atellica IM Ferritin Assay
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Kira Gordon
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Kira Gordon
Regulation Number866.5340
Classification Product Code
DBF  
Date Received06/02/2017
Decision Date 08/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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