510(k) Report

Devices descending from K923048

35 later devices reach Accu-Chek Easy Blood Glucose System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982076Amira Medical Atlast Blood Glucose Monitoring SystemAmira Medical, Inc.199834—
+2K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision…Abbott Laboratories20020—
+2K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.2000332
+3K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc.20104Class I
+3K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.2006102
+3K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200512—
+3K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc.200318—
+3K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc.200222—
+3K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200123—
+3K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.20017—
+4K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+4K111874Freestyle Insulinx Blood Glucose Monitoring SystemsAbbott Laboratories20122—
+4K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+4K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+4K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+4K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+4K063026OK Meter Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20070—
+4K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+4K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+4K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.200211
+4K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20022—
+5K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.20170—
+5K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+5K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+5K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+5K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20121Class I
+5K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc.20101—
+5K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc.20102Class I
+5K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+6K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—
+6K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories20150—
+6K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+6K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+6K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—
+6K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—