FDA.report

510(k) K160682

Device
CONTOUR NEXT ONE Blood Glucose Monitoring System
Applicant
ASCENSIA DIABETES CARE
510(k) number
K160682
Product code
NBW  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-17
Date received
2016-03-10
Regulation
862.1345
Classification name
System, Test, Blood Glucose, Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Roger Sonnenburg
Address
430 S. Beiger St. Mishawaka IN US 46544 46544

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
40301937824010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.2018-09-19
40301939767018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.2017-11-17
40301939766011CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.2017-02-17
40301939765014CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.2016-12-16
40301939763010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.2016-12-16
00301937818011CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.2016-12-16

Legacy Summary

summary

FDA Review

Decision Summary