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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K183007
Device Name EliA SmDP Immunoassay
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
LKP  
Date Received10/31/2018
Decision Date 12/24/2018
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
Predetermined Change
Control Plan Authorized		 No
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