MONITORX LASERX THEOPHYLLINE REAGENT SET

Fluorescence Polarization Immunoassay, Theophylline

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Monitorx Laserx Theophylline Reagent Set.

Pre-market Notification Details

Device IDK870277
510k NumberK870277
Device Name:MONITORX LASERX THEOPHYLLINE REAGENT SET
ClassificationFluorescence Polarization Immunoassay, Theophylline
Applicant AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
ContactLuann Ochs
CorrespondentLuann Ochs
AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
Product CodeLGS  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-27
Decision Date1987-02-18

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