PAP ANTIBODY KIT

Kappa, 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 Pap Antibody Kit.

Pre-market Notification Details

Device IDK924629
510k NumberK924629
Device Name:PAP ANTIBODY KIT
ClassificationKappa, Peroxidase, Antigen, Antiserum, Control
Applicant VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DR. Tucson,  AZ  85705
ContactStephen A Tillson
CorrespondentStephen A Tillson
VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DR. Tucson,  AZ  85705
Product CodeDFD  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-14
Decision Date1993-02-04

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