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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hepatitis A Test (Antibody And Igm Antibody)
510(k) Number K161964
Device Name ADVIA Centaur HAV IgM Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Philip Liu
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Philip Liu
Regulation Number866.3310
Classification Product Code
LOL  
Date Received07/18/2016
Decision Date 10/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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