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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, Thyroglobulin
510(k) Number K242981
Device Name Atellica IM Thyroglobulin (Tg)
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Mey Vasquez
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Mey Vasquez
Regulation Number866.6010
Classification Product Code
MSW  
Subsequent Product Code
JJX  
Date Received09/26/2024
Decision Date 06/20/2025
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
Predetermined Change
Control Plan Authorized		 No
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