Contour® Next GEN Blood Glucose Monitoring System

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 Gen Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK193407
510k NumberK193407
Device Name:Contour® Next GEN Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Ascensia Diabetes Care 100 Summit Lake Drive Valhalla,  NY  10595
ContactColleen Burdel
CorrespondentColleen Burdel
Ascensia Diabetes Care 100 Summit Lake Drive Valhalla,  NY  10595
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2021-12-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00301933537015 K193407 000
00301933536018 K193407 000
40301939658019 K193407 000
40301937383012 K193407 000
00301937917011 K193407 000

Trademark Results [Contour]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTOUR
CONTOUR
98571821 not registered Live/Pending
Corning Optical Communications LLC
2024-05-28
CONTOUR
CONTOUR
98388200 not registered Live/Pending
Scientific Games, LLC
2024-02-02
CONTOUR
CONTOUR
98297430 not registered Live/Pending
Automatic Devices Company
2023-12-04
CONTOUR
CONTOUR
98296265 not registered Live/Pending
Tessaract Materials Inc
2023-12-03
CONTOUR
CONTOUR
98285099 not registered Live/Pending
Tessaract Materials Inc
2023-11-25
CONTOUR
CONTOUR
98250537 not registered Live/Pending
Pinta Elements GmbH
2023-11-01
CONTOUR
CONTOUR
98235446 not registered Live/Pending
Landscape Forms, Inc.
2023-10-23
CONTOUR
CONTOUR
98126123 not registered Live/Pending
Helm Agro US, Inc.
2023-08-10
CONTOUR
CONTOUR
98113404 not registered Live/Pending
Prollenium Medical Technologies, Inc.
2023-08-02
CONTOUR
CONTOUR
98092158 not registered Live/Pending
Tulster, LLC
2023-07-19
CONTOUR
CONTOUR
98038281 not registered Live/Pending
Singer Sourcing Limited LLC
2023-06-12
CONTOUR
CONTOUR
97841816 not registered Live/Pending
Ridgeline International, Inc.
2023-03-16

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