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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Blood Test For Amyloid Pathology Assessment
510(k) Number K252163
Device Name Elecsys Phospho-Tau (181P) Plasma
Applicant
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Applicant Contact Stephan Knierer
Correspondent
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Correspondent Contact Stephan Knierer
Classification Product Code
SET  
Date Received07/10/2025
Decision Date 10/08/2025
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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