VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

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 Her2 (4b5).

Pre-market Notification Details

Device IDK121516
510k NumberK121516
Device Name:VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
ClassificationMicroscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Applicant VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos,  CA  94022
ContactErika Ammirati
CorrespondentErika Ammirati
VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos,  CA  94022
Product CodeNQN  
Subsequent Product CodeNOT
Subsequent Product CodeOEO
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-22
Decision Date2013-09-26
Summary:summary

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