VIRTUOSO SYSTEM FOR IHC PR (IE2)

Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

VENTANA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso System For Ihc Pr (ie2).

Pre-market Notification Details

Device IDK111869
510k NumberK111869
Device Name:VIRTUOSO SYSTEM FOR IHC PR (IE2)
ClassificationMicroscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Applicant VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson,  AZ  85755
ContactTroy Quander
CorrespondentTroy Quander
VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson,  AZ  85755
Product CodeNQN  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-01
Decision Date2012-03-05
Summary:summary

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