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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 K110736
Device Name ADVIA CHEMISTRY FERRITIN (FRT) METHOD
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10509
Applicant Contact KIRA GORDON
Correspondent
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10509
Correspondent Contact KIRA GORDON
Regulation Number866.5340
Classification Product Code
DBF  
Subsequent Product Code
JIX  
Date Received03/16/2011
Decision Date 08/17/2011
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
Recalls CDRH Recalls
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