INNOFLUOR THEOPHYLLINE

Fluorescence Polarization Immunoassay, Theophylline

INNOTRON DIAGNOSTICS

The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Theophylline.

Pre-market Notification Details

Device IDK850629
510k NumberK850629
Device Name:INNOFLUOR THEOPHYLLINE
ClassificationFluorescence Polarization Immunoassay, Theophylline
Applicant INNOTRON DIAGNOSTICS 6-A FARADAY Irvine,  CA  92718
ContactMarija Valentekovich
CorrespondentMarija Valentekovich
INNOTRON DIAGNOSTICS 6-A FARADAY Irvine,  CA  92718
Product CodeLGS  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-19
Decision Date1985-03-12

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