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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 K063775
Device Name ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
Applicant
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5750
Classification Product Code
MST  
Subsequent Product Code
JJY  
Date Received12/21/2006
Decision Date 03/14/2007
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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