PSA ANTIBODY KIT

Lambda, 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 Psa Antibody Kit.

Pre-market Notification Details

Device IDK932326
510k NumberK932326
Device Name:PSA ANTIBODY KIT
ClassificationLambda, Antigen, Antiserum, Control
Applicant VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson,  AZ  85705
ContactStephen A Tillson
CorrespondentStephen A Tillson
VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson,  AZ  85705
Product CodeDEH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-28
Decision Date1993-08-06

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