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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, Thyroid Autoantibody
510(k) Number K151799
Device Name EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
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 MARTIN ROBERT MANN
Regulation Number866.5870
Classification Product Code
JZO  
Subsequent Product Code
JJY  
Date Received07/02/2015
Decision Date 03/25/2016
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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