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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 K123275
Device Name IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
Applicant
Phadia AB
4169 Commercial Ave.
Portae,  MI  49002
Applicant Contact MARTIN MANN
Correspondent
Phadia AB
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact MARTIN MANN
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/19/2012
Decision Date 06/28/2013
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
Recalls CDRH Recalls
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