FDA 510(k) Applications Submitted by Roche Diabetes Care, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K214022 12/22/2021 Accu-Chek Softclix Blood Lancing System Roche Diabetes Care, Inc.
K220849 03/23/2022 Accu-Chek Safe-T-Pro Plus Lancing Device Roche Diabetes Care, Inc.
K220364 02/08/2022 Accu-Chek Safe-T-Pro Uno Lancing Device Roche Diabetes Care, Inc.
K232488 08/17/2023 Accu-Chek Safe-T-Pro Plus Lancing Device Roche Diabetes Care, Inc.
K232509 08/18/2023 Accu-Chek Safe-T-Pro Uno Lancing Device Roche Diabetes Care, Inc.
K160944 04/05/2016 ACCU-CHEK Guide Blood Glucose Monitoring System Roche Diabetes Care, Inc.


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