510(k) Report

Devices descending from K100398

5 later devices reach Smartlink Gold Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor20170—
+1K132929SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor…Sd Biosensor, Inc.20151—
+1K123517Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring…Sd Biosensor20141—
+2K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi…Sd Biosensor20160—
+2K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…Sd Biosensor20150—