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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.
K160944
04/05/2016
ACCU-CHEK Guide Blood Glucose Monitoring System
Roche Diabetes Care, Inc.
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