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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, carcinoembryonic antigen
510(k) Number K200215
Device Name ADVIA Centaur CEA Assay
Applicant
Siemens Healthcare Disgnostics Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Mey Lyn Vasquez
Correspondent
Siemens Healthcare Disgnostics Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Mey Lyn Vasquez
Regulation Number866.6010
Classification Product Code
DHX  
Date Received01/28/2020
Decision Date 04/13/2020
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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