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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 K190710
Device Name EliA SymphonyS Immunoassay
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE SE 754 50
Applicant Contact Carina Magnusson
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact Sheryl Skinner
Regulation Number866.5100
Classification Product Code
LLL  
Date Received03/19/2019
Decision Date 11/29/2019
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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