510(k) Report

Devices descending from K031755

15 later devices reach Accu-Chek Compact Test Strip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113614Accu-Check Compact Plus Blood Glucose Monitoring SystemRoche Diagnostics201301
+1K050872Accu-Chek Integra SystemRoche Diagnostics Corp.20050—
+1K040796Accu-Chek GO SystemRoche Diagnostics Corp.2004122
+2K082169Pro Glucose Test StripTaidoc Technology Corporation200810—
+2K051592Modification to Accu-Chek GO SystemRoche Diagnostics Corp.20050—
+3K092688Fora Poct S10/TD-4258 Blood Glucose Monitoring SystemTaidoc Technology Corporation20110—
+3K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation20106—
+3K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation20101—
+4K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation20191—
+4K181588POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation20180—
+4K173511ActiveCare TD-4121 Blood Glucose Monitoring SystemTaidoc Technology Corporation20180—
+4K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation20180—
+4K113768U-Right TD-4280 Blood Glucose Monitoring SystemTaidoc Technology Corporation20120—
+4K111890Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood Glucose…Taidoc Technology Corporation20120—
+5K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose…Vivachek Biotech (Hangzhou) Co., Ltd.20240—