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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 K122197
Device Name AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Applicant
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Applicant Contact MARTIN MANN
Correspondent
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Correspondent Contact MARTIN MANN
Regulation Number866.5750
Classification Product Code
DHB  
Date Received07/24/2012
Decision Date 08/28/2013
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
Recalls CDRH Recalls
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