SENSOREX BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

CHRONIMED, INC.

The following data is part of a premarket notification filed by Chronimed, Inc. with the FDA for Sensorex Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK980573
510k NumberK980573
Device Name:SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant CHRONIMED, INC. 6214 BURY DR. Eden Prairie,  MN  55346
ContactJeffrey P Heaton
CorrespondentJeffrey P Heaton
CHRONIMED, INC. 6214 BURY DR. Eden Prairie,  MN  55346
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-17
Decision Date1998-07-30

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