510(k) Report

Devices descending from K053079

2 later devices reach Assure Pro Blood Glucose Monitoring System, Model 460001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092104Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc.20090—
+1K090332Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc.20090—