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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 K113377
Device Name GLIADIN IGA AND GLIADIN LGA
Applicant
Grifols USA, LLC
2410 Lillyvale Ave.
Los Angeles,  CA  90032
Applicant Contact CATHERINE L WONG
Correspondent
Grifols USA, LLC
2410 Lillyvale Ave.
Los Angeles,  CA  90032
Correspondent Contact CATHERINE L WONG
Regulation Number866.5750
Classification Product Code
MST  
Date Received11/16/2011
Decision Date 12/14/2012
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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