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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Endomysial(Tissue Transglutaminase)
510(k) Number K102964
Device Name EU-TTG IGA AND EU-TTG IGG
Applicant
Grifols USA, Inc.
2410 Lillyvale Ave.
Los Angeles,  CA  90032
Applicant Contact CATHERINE L WONG
Correspondent
Grifols USA, Inc.
2410 Lillyvale Ave.
Los Angeles,  CA  90032
Correspondent Contact CATHERINE L WONG
Regulation Number866.5660
Classification Product Code
MVM  
Date Received10/05/2010
Decision Date 03/07/2011
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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