Contour Next EZ Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Ascensia Diabetes Care US Inc.

The following data is part of a premarket notification filed by Ascensia Diabetes Care Us Inc. with the FDA for Contour Next Ez Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK162336
510k NumberK162336
Device Name:Contour Next EZ Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Ascensia Diabetes Care US Inc. 430 South Beiger Street Mishawaka,  IN  46544
ContactJennifer L. Gregory
CorrespondentJennifer L. Gregory
Ascensia Diabetes Care US Inc. 430 South Beiger Street Mishawaka,  IN  46544
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-22
Decision Date2017-01-12
Summary:summary

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