NOVA View Automated Fluorescense Microscope

Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use

INOVA DIAGNOSTICS, INC.

The following data is part of a De Novo classification by Inova Diagnostics, Inc. with the FDA for Nova View Automated Fluorescense Microscope.

Pre-market Notification Details

DeNovo IDDEN140039
Device Name:NOVA View Automated Fluorescense Microscope
ClassificationAutomated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use
Applicant INOVA DIAGNOSTICS, INC. 9900 Old Grove Road San Diego,  CA  92131
ContactGabriella Lakos
Product CodePIV  
CFR Regulation Number866.4750 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardImmunology
Classification AdvisoryImmunology
TypePost-NSE
Date Received2014-12-15
Decision Date2015-04-09
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950643708 DEN140039 000
08426950621614 DEN140039 000

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