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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 K250666
Device Name Alegria Flash CTD Screen
Applicant
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact Mark Kopnitsky
Correspondent
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact Mark Kopnitsky
Regulation Number866.5100
Classification Product Code
LLL  
Date Received03/05/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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