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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 K121463
Device Name IMMUNOCAP ALLERGEN K82
Applicant
Thermo Fisher Scientific
4169 COMMERCIAL AVENUE
PORTAGE,  MI  49002
Applicant Contact MARTIN MANN
Correspondent
Thermo Fisher Scientific
4169 COMMERCIAL AVENUE
PORTAGE,  MI  49002
Correspondent Contact MARTIN MANN
Regulation Number866.5750
Classification Product Code
DHB  
Date Received05/17/2012
Decision Date 01/29/2013
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
Recalls CDRH Recalls
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