510(k) Report

Devices descending from K021513

15 later devices reach Accu-Chek Advantage Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc.20091—
+1K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc.20070—
+1K052469GlucopackHealthpia America Corp.20061—
+1K051651G4, Model Igm-0004U. S. Diagnostics, Inc.20060—
+1K051285Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd.20056—
+1K043512Easygluco Igm-0002 G2American Healthcare, Inc.20050—
+1K043543Blood Glucose Monitoring SystemAmerican Healthcare, Inc.20050—
+1K031501Easygluco, Model IGM0002American Healthcare, Inc.20030—
+2K110435Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc.20110—
+2K091168Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd.20100—
+2K091157Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd.20092—
+2K090712Eocene SystemInfopia Co, Ltd.20090—
+2K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd.20090—
+3K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+4K132862Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.20130—