510(k) Report

Devices descending from K982002

49 later devices reach Accu-Chek Comfort Curve Test Strip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013068Bioscanner 2000Polymer Technology Systems, Inc.200151
+1K013203Bioscanner Beyond Glucose Analyzer and Test StripsPolymer Technology Systems, Inc.20018—
+1K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.2000332
+2K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc.20104Class I
+2K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc.200724
+2K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071—
+2K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.2006102
+2K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200512—
+2K041750PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc.200411
+2K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc.200318—
+2K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc.200222—
+2K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision…Abbott Laboratories20020—
+2K014099Bioscanner PlusPolymer Technology Systems, Inc.20017—
+2K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200123—
+2K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.20017—
+3K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201602
+3K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.201564
+3K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc.20140—
+3K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+3K111874Freestyle Insulinx Blood Glucose Monitoring SystemsAbbott Laboratories20122—
+3K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+3K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+3K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+3K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+3K063026OK Meter Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20070—
+3K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+3K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+3K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.200211
+3K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20022—
+4K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics20220—
+4K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201801
+4K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.20170—
+4K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.20171—
+4K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc.201602
+4K151530CardioChek Plus Test SystemPolymer Technology Systems, Inc.20150—
+4K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+4K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+4K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+4K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20121Class I
+4K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc.20101—
+4K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc.20102Class I
+4K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+5K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—
+5K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—
+5K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories20150—
+5K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+5K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+5K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—
+5K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—