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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Ss-A 52 Autoantibodies
510(k) Number K250814
Device Name Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
Applicant
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact Daniel Zweitzig
Correspondent
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact Daniel Zweitzig
Regulation Number866.5100
Classification Product Code
OBE  
Subsequent Product Codes
LLL   PET  
Date Received03/17/2025
Decision Date 05/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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