510(k) Report

Devices descending from K103396

1 later device reach Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121654Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control SolutionI-Sens, Inc.20120—