510(k) Report

Devices descending from K952279

46 later devices reach Precision Link Blood Glucose Data Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040628Precision Link Diabetes Data Management SystemAbbott Laboratories20044—
+1K994433Connect Data Management SystemAbbott Diabetes Care, Inc.2000391
+1K983468Fasttake Adapter, Model # P/N 020-072-01Selfcare, Inc.19980—
+2K062770Copilot Health Management SystemAbbott Diabetes Care, Inc.20063—
+2K062434Zero-Click Data Management System, Model 8000-01528Agamatrix200614—
+2K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc.200222—
+2K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200123—
+3K123089Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001Abbott Laboratories20130—
+3K111874Freestyle Insulinx Blood Glucose Monitoring SystemsAbbott Laboratories20122—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K100937PC Care Blood Glucose Data Management SoftwareI-Sens, Inc.20101—
+3K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix201011—
+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—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K132821Agamatrix Health ManagerAgamatrix, Inc.20130—
+4K123136Genesis Health Record System, (GHRS)Genesis Health Technologies20130—
+4K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20121Class I
+4K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+4K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc.20119—
+4K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+4K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+4K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+4K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+4K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+5K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc.20161—
+5K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories20150—
+5K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc.20144—
+5K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc.20131—
+5K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+5K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+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—
+6K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc.20160—
+6K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.201521
+6K150299Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+6K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+6K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+6K132148S HealthSamsung Electronics Co., Ltd.20130—
+6K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—
+6K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—
+7K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd.20180—
+7K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.20170—