CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitorin

System, Test, Blood Glucose, Over The Counter

Ascensia Diabetes Care

The following data is part of a premarket notification filed by Ascensia Diabetes Care with the FDA for Contour® Next Blood Glucose Monitoring System, Contour® Next Usb Blood Glucose Monitoring System, Contour® Next One Blood Glucose Monitoring System, Contour® Next Ez Blood Glucose Monitoring System, Contour® Next Link Wireless Blood Glucose Monitorin.

Pre-market Notification Details

Device IDK191286
501k NumberK191286
Device Name:CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitorin
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Ascensia Diabetes Care 100 Summit Lake Drive Valhalla,  NY  10595
ContactStacie Geffner-atiya
CorrespondentStacie Geffner-atiya
Ascensia Diabetes Care 100 Summit Lake Drive Valhalla,  NY  10595
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
501k Review PanelClinical Chemistry
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2019-11-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40301937550155 K191286 000

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