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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K123880
Device Name QUANTA FLASH CENTROMERE
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Applicant Contact ANDREA SEAMAN
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Correspondent Contact ANDREA SEAMAN
Regulation Number866.5100
Classification Product Code
LJM  
Subsequent Product Codes
JIX   JJX  
Date Received12/17/2012
Decision Date 02/07/2014
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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