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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, rheumatoid factor
510(k) Number K182747
Device Name EliA RF IgM Immunoassay
Applicant
Phadia AB
Rapsgatan 7P
Uppsala,  SE SE 754 50
Applicant Contact Carina Magnusson
Correspondent
Phadia US Inc.
4169 Commercial Avenue
Portage,  MI  49002
Correspondent Contact Sheryl Skinner
Regulation Number866.5775
Classification Product Code
DHR  
Date Received09/28/2018
Decision Date 12/18/2018
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
Recalls CDRH Recalls
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