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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 K011570
Device Name QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
Applicant
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131 -1234
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131 -1234
Correspondent Contact BRYS C MYERS
Regulation Number866.5660
Classification Product Code
MVM  
Date Received05/21/2001
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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