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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 K193604
Device Name Aptiva Celiac Disease IgA Reagent
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Road
San Diego,  CA  92131 -1638
Applicant Contact Andrea Seaman
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Road
San Diego,  CA  92131 -1638
Correspondent Contact Ronda Elliott
Regulation Number866.5660
Classification Product Code
MVM  
Subsequent Product Codes
MST   NSU  
Date Received12/23/2019
Decision Date 06/16/2021
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
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