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Roche Diabetes Care, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories3
Latest FDA decision2023-11-13
TypeNumberDevice NameCodeDateActions
510(k) K232488 Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK2023-11-13 View
510(k) K232509 Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK2023-11-13 View
510(k) K220849 Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK2022-05-19 View
510(k) K203711 IWL2020 Blood Glucose Monitoring SystemNBW2022-05-06 View
510(k) K220608 Accu-Chek FastClix Blood Lancing SystemQRL2022-04-29 View
510(k) K220364 Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK2022-04-05 View
510(k) K214022 Accu-Chek Softclix Blood Lancing SystemQRL2022-02-17 View
510(k) K160944 ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW2016-08-31 View