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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test system, antineutrophil cytoplasmic antibodies (anca)
510(k) Number K161258
Device Name NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE ROAD
san diego,  CA  92131
Applicant Contact gabriella lakos
Correspondent
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE ROAD
san diego,  CA  92131
Correspondent Contact gabriella lakos
Regulation Number866.5660
Classification Product Code
MOB  
Date Received05/04/2016
Decision Date 02/03/2017
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
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