510(k) Report

Devices descending from K090389

4 later devices reach AP-1000 Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+1K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp.20120—
+1K103044AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.20120—
+1K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp.20120—