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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 K101644
Device Name QUANTA FLASH H-TTG IGG
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact RUFUS BURLINGAME
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact RUFUS BURLINGAME
Regulation Number866.5660
Classification Product Code
MVM  
Subsequent Product Codes
JIX   JJX  
Date Received06/10/2010
Decision Date 03/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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