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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name automated indirect immunofluorescence microscope and software-assisted system for clinical use
De Novo Number DEN140039
Device Name NOVA View Automated Fluorescense Microscope
Requester
inova diagnostics, inc.
9900 old grove road
san diego,  CA  92131
Contact gabriella lakos
Regulation Number866.4750
Classification Product Code
PIV  
Date Received12/15/2014
Decision Date 04/09/2015
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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