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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name extractable antinuclear antibody, antigen and control
510(k) Number K122923
Device Name QUANTA FLASH ENA7
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE RD.
SAN DIEGO,  CA  92131 -1638
Applicant Contact MICHAEL MAHLER
Correspondent
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE RD.
SAN DIEGO,  CA  92131 -1638
Correspondent Contact MICHAEL MAHLER
Regulation Number866.5100
Classification Product Code
LLL  
Subsequent Product Codes
JIX   JJX  
Date Received09/24/2012
Decision Date 05/07/2013
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
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