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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, radioallergosorbent (rast) immunological
510(k) Number K151029
Device Name Phadia Prime
Applicant
PHADIA AB
RAPSGATAN 7P
UPPSALA,  SE 75137
Applicant Contact Anna-Lisa Tiensuu
Correspondent
Phadia US Inc.
4169 Commercial Avenue
Portage,  MI  49002
Correspondent Contact Martin Mann
Regulation Number866.5750
Classification Product Code
DHB  
Subsequent Product Code
LKJ  
Date Received04/17/2015
Decision Date 01/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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