Ascensia Diabetes Care

FDA Filings

This page includes the latest FDA filings for Ascensia Diabetes Care. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Ascensia Diabetes Care
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 Monitorin2019-11-08
ASCENSIA DIABETES CARE
CONTOUR NEXT ONE Blood Glucose Monitoring System2016-11-17

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
CONTOUR®NEXT
ASCENSIA DIABETES CARE US INC.2019-11-22
KETO-DIASTIX®
ASCENSIA DIABETES CARE US INC.2019-06-14
KETO-DIASTIX®
ASCENSIA DIABETES CARE US INC.2019-06-14
KETOSTIX®
ASCENSIA DIABETES CARE US INC.2019-06-14
KETOSTIX®
ASCENSIA DIABETES CARE US INC.2019-06-14
MICROLET®NEXT
ASCENSIA DIABETES CARE US INC.2019-06-14
MICROLET®NEXT
ASCENSIA DIABETES CARE US INC.2019-06-14
MICROLET®NEXT
ASCENSIA DIABETES CARE US INC.2019-06-14
MICROLET®
ASCENSIA DIABETES CARE US INC.2019-06-14
CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET®
ASCENSIA DIABETES CARE US INC.2019-06-14
CONTOUR® NEXT and MICROLET®
ASCENSIA DIABETES CARE US INC.2019-06-14
ABOUND®
ASCENSIA DIABETES CARE US INC.2019-06-14
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
DIASTIX®
ASCENSIA DIABETES CARE US INC.2019-06-07
DIASTIX®
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT LINK
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT LINK
ASCENSIA DIABETES CARE US INC.2019-06-07
BREEZE® 2
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT LINK
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR®
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT LINK 2.4
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT LINK 2.4
ASCENSIA DIABETES CARE US INC.2019-06-07
CONTOUR® NEXT LINK
ASCENSIA DIABETES CARE US INC.2019-06-07

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