510(k) Report

Devices descending from K911801

41 later devices reach Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Medisense, Inc.1999401
+2K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc.20080—
+2K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsAbbott Diabetes Care, Inc.200601
+2K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc.200519—
+2K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories2004163
+2K033845Precision Xceed Diabetes Monitoring SystemAbbott Laboratories200402
+2K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision…Abbott Laboratories20020—
+3K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp.201010Class I
+3K080960Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models…Abbott Diabetes Care, Inc.20083—
+3K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.20070—
+3K063855Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution…Liberty Healthcare Group, Inc.20071—
+3K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc.20068—
+3K060426Liberty Glucose Normal Control Solutions, Model 2120041Liberty Healthcare Group, Inc.20061—
+3K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+4K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20220—
+4K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20210—
+4K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.20180—
+4K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.20181—
+4K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation20162—
+4K130094Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care20132—
+4K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+4K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp.20100—
+4K090943Abt Glucose Control Solution, Model: 2120089American Biological Technologies, Inc.20090—
+4K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+4K080273AB-Trol and Private Label Glucose Control SolutionFujirebio Diagnostics Texas, Inc.20080—
+4K081915FDTX Glucose Control SolutionFujirebio Diagnostics Texas, Inc.20081—
+4K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+4K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.20075—
+5K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—
+5K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20200—
+5K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation20180—
+5K132511Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc.20131—
+5K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc.20101—
+5K090854Abt Glucose Control Solution, Model 2120090American Biological Technologies, Inc.20090—
+5K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+5K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+6K153330FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20160—
+6K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+6K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—
+6K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—
+7K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—