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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K251543
Device Name Atellica® IM TSH3-Ultra II (TSH3ULII)
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact Kelly Scuderi
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Kelly Scuderi
Regulation Number862.1690
Classification Product Code
JLW  
Date Received05/20/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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