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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 K150854
Device Name ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE 751 37
Applicant Contact Carina Magnusson
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact Martin Mann
Regulation Number866.5750
Classification Product Code
DHB  
Date Received03/31/2015
Decision Date 12/14/2015
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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