AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK 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 Auto-chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-check Control Solution.

Pre-market Notification Details

Device IDK121654
510k NumberK121654
Device Name:AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK 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 Received2012-06-05
Decision Date2012-09-05
Summary:summary

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