CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)

Antibody Igm,if, Cytomegalovirus Virus

IMMUNO CONCEPTS, INC.

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

Pre-market Notification Details

Device IDK893465
510k NumberK893465
Device Name:CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
ClassificationAntibody Igm,if, Cytomegalovirus Virus
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 CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-03
Decision Date1989-07-25

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