510(k) Report

Devices descending from K043311

9 later devices reach Ascensia Elite Diabetes Care System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+1K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp.20076—
+2K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—
+2K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp.20094—
+2K072274Major Iii Blood Glucose Monitoring SystemBestgen Biotech Corp.20080—
+3K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+3K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp.20120—
+3K103044AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+3K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp.20120—