IMMPULSE TOBRAMYCIN ASSAY REAGENTS

Fluorescent Immunoassay, Tobramycin

PARAGON DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Paragon Diagnostics, Inc. with the FDA for Immpulse Tobramycin Assay Reagents.

Pre-market Notification Details

Device IDK840847
510k NumberK840847
Device Name:IMMPULSE TOBRAMYCIN ASSAY REAGENTS
ClassificationFluorescent Immunoassay, Tobramycin
Applicant PARAGON DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLCR  
CFR Regulation Number862.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-24
Decision Date1984-04-04

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