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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K253367
Device Name EliA CTD 13 Screen
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE 751 37
Applicant Contact Darleen Welford
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact Carla Krause
Regulation Number866.5100
Classification Product Code
LLL  
Subsequent Product Codes
LSW   MQA   NYO  
Date Received09/30/2025
Decision Date 06/25/2026
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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