Ascensia Diabetes Care - FDA 510(k) Cleared Devices
Recent clearances: CONTOUR® PLUS BLUE Blood Glucose Monitoring System, CONTOUR® PLUS BLUE Blood Glucose Monitoring System, Contour® next GEN Blood Glucose Monitoring System
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ascensia Diabetes Care Chemistry ✕
6 devices
Cleared
Aug 27, 2026
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
Chemistry
190d
Cleared
CT
Feb 23, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
Chemistry
259d
Cleared
Dec 23, 2021
Contour® next GEN Blood Glucose Monitoring System
Chemistry
745d
Cleared
Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
Chemistry
156d
Cleared
Nov 08, 2019
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood...
Chemistry
179d
Cleared
CT
Nov 17, 2016
CONTOUR NEXT ONE Blood Glucose Monitoring System
Chemistry
252d