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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 K071692
Device Name THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
Applicant
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Applicant Contact MARIUS TEODORESCU
Correspondent
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Correspondent Contact MARIUS TEODORESCU
Regulation Number866.5660
Classification Product Code
MVM  
Subsequent Product Code
MST  
Date Received06/20/2007
Decision Date 11/05/2007
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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