510(k) Report

Devices descending from K092638

4 later devices reach Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+2K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+2K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+3K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—