Contour Next USB Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

BAYER HEALTHCARE

The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Usb Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK150942
510k NumberK150942
Device Name:Contour Next USB Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant BAYER HEALTHCARE DIABETES CARE 430 SOUTH BEIGER STREET Mishawaka,  IN  46544
ContactJennifer L. Gregory
CorrespondentJennifer L. Gregory
BAYER HEALTHCARE 430 South Beiger St. Mishawaka,  IN  46544
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-08
Decision Date2015-11-25
Summary:summary

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