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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cytokeratin Fragments 21-1 Eia Kit
510(k) Number K250925
Device Name ADVIA Centaur Cytokeratin Fragment 21-1
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19475
Applicant Contact Kristin Maddaloni
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19475
Correspondent Contact Kristin Maddaloni
Regulation Number866.6010
Classification Product Code
OVK  
Date Received03/27/2025
Decision Date 12/16/2025
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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