VENTANA RED DETECTION KIT

Igm, Peroxidase, Antigen, Antiserum, Control

VENTANA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventana Red Detection Kit.

Pre-market Notification Details

Device IDK932386
510k NumberK932386
Device Name:VENTANA RED DETECTION KIT
ClassificationIgm, Peroxidase, Antigen, Antiserum, Control
Applicant VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DR. Tucson,  AZ  85705
ContactStephen A Tilllson
CorrespondentStephen A Tilllson
VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DR. Tucson,  AZ  85705
Product CodeDEY  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-17
Decision Date1993-08-09

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