510(k) Report

Devices descending from K160944

3 later devices reach ACCU-CHEK Guide Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH20230—
+1K203711IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care, Inc.20220—
+1K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemRoche Diabetes Care20180—