510(k) Report

Devices descending from K964630

23 later devices reach Glucometer Elite Blood Glucose Meter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061234Glucoplus Blood Glucose Monitoring SystemGlucoplus, Inc.20060—
+1K0502243TEST Glucose Monitoring SystemNeuero Engineering, Inc.20051—
+1K043340EZ SmartVip Diagnostics, LLC20050—
+1K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC20049—
+1K040848EZ SmartVip International Wholesalers, Corp.20048—
+1K991480Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc.19990—
+2K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+2K0729053TEST Supreme Glucose Monitoring SystemNeuero Engineering, Inc.20080—
+2K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp.20076—
+2K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc.20066—
+3K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—
+3K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp.20094—
+3K072441EZ Scan Plus Blood Glucose Monitoring SystemTyson Bioresearch, Inc.20080—
+3K072274Major Iii Blood Glucose Monitoring SystemBestgen Biotech Corp.20080—
+3K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc.20064—
+4K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+4K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp.20120—
+4K103044AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+4K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+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—