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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Ribosomal P Antibodies
510(k) Number K202540
Device Name EliA Rib-P
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE SE 754 50
Applicant Contact Carina Magnusson
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact Sheryl Skinner
Regulation Number866.5100
Classification Product Code
MQA  
Date Received09/02/2020
Decision Date 09/13/2021
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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