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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 K043433
Device Name AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
Applicant
Hycor Biomedical , Ltd.
Pentlands Science Park
Bush Loan
Penicuik, Midlothian,  GB EH26 OPL
Applicant Contact DANIELLE M KNIGHT
Correspondent
Hycor Biomedical , Ltd.
Pentlands Science Park
Bush Loan
Penicuik, Midlothian,  GB EH26 OPL
Correspondent Contact DANIELLE M KNIGHT
Regulation Number866.5660
Classification Product Code
MVM  
Date Received12/13/2004
Decision Date 03/07/2005
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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