BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT

Glucose Oxidase, Glucose

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Glucose Enzymatique Color Reagent.

Pre-market Notification Details

Device IDK873117
510k NumberK873117
Device Name:BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
ClassificationGlucose Oxidase, Glucose
Applicant BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-10
Decision Date1987-08-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.