VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemical Assay, Helicobacter Pylori

VENTANA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventana Anti-helicobacter Pylori (sp48) Rabbit Monoclonal Primary Antibody.

Pre-market Notification Details

Device IDK101234
510k NumberK101234
Device Name:VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
ClassificationImmunohistochemical Assay, Helicobacter Pylori
Applicant VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson,  AZ  85755
ContactJudy Howe
CorrespondentJudy Howe
VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. Tucson,  AZ  85755
Product CodeOWF  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-03
Decision Date2011-08-25
Summary:summary

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