ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

ARKRAY FACTORY INC.

The following data is part of a premarket notification filed by Arkray Factory Inc. with the FDA for Arkray Glucocard 01 Blood Glucose Monitoring System And Relion Confirm Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK124021
510k NumberK124021
Device Name:ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant ARKRAY FACTORY INC. 5198 WEST 76TH ST Edina,  MN  55439
ContactLonna M Dendooven
CorrespondentLonna M Dendooven
ARKRAY FACTORY INC. 5198 WEST 76TH ST Edina,  MN  55439
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-27
Decision Date2014-06-30
Summary:summary

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