510(k) Report

Devices descending from K040848

8 later devices reach EZ Smart through their predicates, nearest generation first.

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