IMMPULSE THEOPHYLLINE ASSAY REAGENTS

Fluorescent Immunoassay, Theophylline

PARAGON DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK840758
510k NumberK840758
Device Name:IMMPULSE THEOPHYLLINE ASSAY REAGENTS
ClassificationFluorescent Immunoassay, Theophylline
Applicant PARAGON DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLER  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-23
Decision Date1984-04-04

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