TURBOX THEOPHYLLINE ASSAY

Fluorescent Immunoassay, Theophylline

UNIPATH LTD.

The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Turbox Theophylline Assay.

Pre-market Notification Details

Device IDK882570
510k NumberK882570
Device Name:TURBOX THEOPHYLLINE ASSAY
ClassificationFluorescent Immunoassay, Theophylline
Applicant UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg,  GB
ContactMr. G Zajicek
CorrespondentMr. G Zajicek
UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg,  GB
Product CodeLER  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-22
Decision Date1988-11-10

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