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Ascensia Diabetes Care U.S., Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories3
Latest Approval2025-05-14
TypeNumberDevice NameCodeDate
510(k) K250813 MICROLET®NEXT 2 Lancing Device QRL 2025-05-14 View
510(k) K241787 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System NBW 2024-08-27 View
510(k) K241810 MICROLET®NEXT Lancet QRK 2024-08-15 View
510(k) K223293 CONTOUR® NEXT GEN Blood Glucose Monitoring System NBW 2022-11-18 View
510(k) K220633 MICROLET NEXT lancing device, MICROLET Lancet QRL 2022-06-03 View
510(k) K162336 Contour Next EZ Blood Glucose Monitoring System NBW 2017-01-12 View
510(k) K160430 Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System NBW 2016-06-24 View