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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 K041354
Device Name VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
Applicant
Sweden Diagnostics (Germany) GmbH
Munzingerstrasse 7
Freiburg,  DE D-79111
Applicant Contact MICHAEL LINSS
Correspondent
Sweden Diagnostics (Germany) GmbH
Munzingerstrasse 7
Freiburg,  DE D-79111
Correspondent Contact MICHAEL LINSS
Regulation Number866.5750
Classification Product Code
MST  
Date Received05/20/2004
Decision Date 07/16/2004
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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