LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

GENETIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Legionella Immunofluorescent Antibody Test Kit.

Pre-market Notification Details

Device IDK852237
510k NumberK852237
Device Name:LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
ClassificationReagents, Antibody, Legionella, Direct & Indirect Fluorescent
Applicant GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
ContactMonica S Krieger
CorrespondentMonica S Krieger
GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
Product CodeLHL  
CFR Regulation Number866.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-22
Decision Date1985-08-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.