510(k) Report

Devices descending from K112638

3 later devices reach Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips through their predicates, nearest generation first.

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