CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION

Glucose Oxidase, Glucose

I-SENS, Inc.

The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose Test Strip, Control Solution.

Pre-market Notification Details

Device IDK120759
510k NumberK120759
Device Name:CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
ClassificationGlucose Oxidase, Glucose
Applicant i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul,  KR 139-845
ContactHyun Joon Oh
CorrespondentHyun Joon Oh
i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul,  KR 139-845
Product CodeCGA  
Subsequent Product CodeJJX
Subsequent Product CodeNBW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-13
Decision Date2012-06-05
Summary:summary

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