GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

I-SENS, Inc.

The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Glucocard Shine Connex Blood Glucose Monitoring System, Glucocard Shine Express Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK181273
510k NumberK181273
Device Name:GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant i-SENS, Inc. 43, Banpo-daero 82-gil, Seocho-gu Seoul,  KR 06646
ContactJoon Ho Jung
CorrespondentJoon Ho Jung
i-SENS, Inc. 43, Banpo-daero 82-gil, Seocho-gu Seoul,  KR 06646
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-14
Decision Date2018-11-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10885325001768 K181273 000

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