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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antibodies, gliadin
510(k) Number K093459
Device Name ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
Applicant
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Applicant Contact MARTIN ROBERT MANN
Correspondent
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Correspondent Contact MARTIN ROBERT MANN
Regulation Number866.5750
Classification Product Code
MST  
Date Received11/06/2009
Decision Date 08/13/2010
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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