CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)

Antisera, Conjugated Fluorescent, Cytomegalovirus

IMMUNO CONCEPTS, INC.

The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Cmv Igg Antibody Test (indirect Enzyme Test).

Pre-market Notification Details

Device IDK893467
510k NumberK893467
Device Name:CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
ClassificationAntisera, Conjugated Fluorescent, Cytomegalovirus
Applicant IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento,  CA  95827
ContactDon W Valencia
CorrespondentDon W Valencia
IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento,  CA  95827
Product CodeLIN  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-03
Decision Date1989-07-14

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