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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Calcitonin
510(k) Number K252431
Device Name Elecsys Calcitonin
Applicant
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Applicant Contact Eva Jad
Correspondent
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Correspondent Contact Eva Jad
Regulation Number862.1140
Classification Product Code
JKR  
Date Received08/01/2025
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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