510(k) Report

Devices descending from K991242

10 later devices reach Glucometer Elite Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043340EZ SmartVip Diagnostics, LLC20050—
+1K040848EZ SmartVip International Wholesalers, Corp.20048—
+1K032029BTG Smartest Glucose Test SystemBt Medical20030—
+2K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc.20066—
+3K072441EZ Scan Plus Blood Glucose Monitoring SystemTyson Bioresearch, Inc.20080—
+3K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc.20064—
+4K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…Tyson Bioresearch, Inc.20083—
+5K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc.20092—
+6K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc.20111—
+7K123087Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood…Tyson Bioresearch, Inc.20130—