LEGIONELLA IFA KIT I

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

BIONETIC LABORATORY PRODUCTS

The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Legionella Ifa Kit I.

Pre-market Notification Details

Device IDK831760
510k NumberK831760
Device Name:LEGIONELLA IFA KIT I
ClassificationReagents, Antibody, Legionella, Direct & Indirect Fluorescent
Applicant BIONETIC LABORATORY PRODUCTS 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 Received1983-06-01
Decision Date1983-08-08

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