510(k) Report

Devices descending from K062058

20 later devices reach Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131727Cera-Chek 1070 Blood Glucose Monitoring SystemCeragem Medisys, Inc.20141—
+1K130181Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.20136—
+1K112916Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring SystemTyson Bioresearch, Inc.20120—
+1K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…Bayer Healthcare, LLC20120—
+1K111268Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare201261
+1K101037EG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017Eps Bio Technology Corp.20110—
+1K090628Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080Bayer Healthcare, LLC20090—
+2K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose…Infopia Co, Ltd.20160—
+2K141829Glucovitaal H1A Blood Glucose Monitoring SystemCeragem Medisys, Inc.20140—
+2K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC20145—
+2K132966Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…Infopia Co, Ltd.20134—
+3K203562Finetest Lite Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd.20210—
+3K182286Oh'Care Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd.20181—
+3K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20171—
+3K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20172—
+3K150274GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose…Infopia Co, Ltd.20150—
+4K201396Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd.20200—
+4K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+4K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20180—
+5K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—