510(k) Report

Devices descending from K000582

23 later devices reach Freestyle Blood Glucose Monitoring System, Cat NO 11001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc.20104Class I
+1K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.2006102
+1K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200512—
+1K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc.200318—
+1K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc.200222—
+2K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+2K111874Freestyle Insulinx Blood Glucose Monitoring SystemsAbbott Laboratories20122—
+2K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+2K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+2K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+2K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+2K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+3K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+3K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+3K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20121Class I
+3K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc.20101—
+3K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc.20102Class I
+3K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+4K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories20150—
+4K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+4K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+4K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—
+4K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—