LEGIONELLA INDIRECT FLUOR. ANTIBODY

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

CENTERS FOR DISEASE CONTROL AND PREVENTION

The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Legionella Indirect Fluor. Antibody.

Pre-market Notification Details

Device IDK812007
510k NumberK812007
Device Name:LEGIONELLA INDIRECT FLUOR. ANTIBODY
ClassificationReagents, Antibody, Legionella, Direct & Indirect Fluorescent
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLHL  
CFR Regulation Number866.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-16
Decision Date1981-09-08

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