Ascensia Diabetes Care FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System510(k)Aug 27, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 27, 2026
CONTOUR® PLUS BLUE Blood Glucose Monitoring System510(k)Feb 23, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 23, 2024
Contour® next GEN Blood Glucose Monitoring System510(k)Dec 23, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Dec 23, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System510(k)Aug 11, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Aug 11, 2021