510(k) Report

Devices descending from K170614

3 later devices reach CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc.20230—
+1K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…I-Sens, Inc.20180—
+1K180866CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc.20180—