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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K163525
Device Name QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Road
San Diego,  CA  92131 -1638
Applicant Contact Peter Martis
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Road
San Diego,  CA  92131 -1638
Correspondent Contact Roger Albesa
Regulation Number866.5090
Classification Product Code
DBM  
Subsequent Product Codes
JIT   JJX  
Date Received12/15/2016
Decision Date 09/05/2017
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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