510(k) Report

Devices descending from K080641

4 later devices reach Trueresult Blood Glucose System E4H01-81 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+1K112352Glucose Meter-Check Control for Nipro TrueresultBionostics, Inc.20110—
+1K091460Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087American Biological Technologies, Inc.20090—
+2K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—