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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K210902
Device Name EliA Ro52, EliA Ro60
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE
Applicant Contact Sheryl Skinner
Correspondent
Phadia, US Lnc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact Jane R Anthony
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received03/26/2021
Decision Date 07/27/2022
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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