510(k) Report

Devices descending from K020208

18 later devices reach Glucometer Elite Diabetes Care System (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042795Clever Chek TD-3213Taidoc Technology Corporation20056—
+1K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC20049—
+1K041107Taidoc CheckTaidoc Technology Corporation20040—
+2K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+2K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp.20076—
+2K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever…Taidoc Technology Corporation20072—
+2K052108Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd.20052—
+3K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—
+3K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation20100—
+3K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp.20094—
+3K080853Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc.20090—
+3K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd.20090—
+3K080014Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring SystemTaidoc Technology Corporation20080—
+3K072274Major Iii Blood Glucose Monitoring SystemBestgen Biotech Corp.20080—
+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—