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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 K242706
Device Name Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Applicant
Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern,  PA  19355
Applicant Contact Stacey Dolan
Correspondent
Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern,  PA  19355
Correspondent Contact Stacey Dolan
Classification Product Code
SET  
Date Received09/09/2024
Decision Date 05/16/2025
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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