510(k) Report

Devices descending from K951887

64 later devices reach Advantage Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982089Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test StripsBoehringer Mannheim Corp.199807
+1K973662Accu-Chek (R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage…Boehringer Mannheim Corp.199702
+1K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.199759—
+1K962295Precision Qid Blood Glucose Test StripMedisense, Inc.199661—
+2K043245Eps Easy Pain Supreme Self Monitoring Blood Glucose SystemEps Bio Technology Corp.20052—
+2K022182Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood…Abbott Laboratories20020—
+2K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Medisense, Inc.1999401
+2K982303Precision PCX Point of Care Management System , QC Manager Data Manager System…Medisense, Inc.199814—
+2K963676Precision G Blood Glucose Testing SystemMedisense, Inc.199760—
+3K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc.20080—
+3K061992Easyplus Self Monitoring Glucose Test System, Model EPS04014Eps Bio Technology Corp.20061—
+3K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsAbbott Diabetes Care, Inc.200601
+3K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc.200519—
+3K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories2004163
+3K033845Precision Xceed Diabetes Monitoring SystemAbbott Laboratories200402
+3K022941Medisense Precision PCX Point of Care Management System for Blood Glucose TestingAbbott Laboratories200213—
+3K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision…Abbott Laboratories20020—
+4K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp.201010Class I
+4K081796Easyplus Mini R2N Self Monitoring Glucose Test SystemEps Bio Technology Corp.20090—
+4K080960Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models…Abbott Diabetes Care, Inc.20083—
+4K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.20070—
+4K063855Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution…Liberty Healthcare Group, Inc.20071—
+4K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc.20068—
+4K060426Liberty Glucose Normal Control Solutions, Model 2120041Liberty Healthcare Group, Inc.20061—
+4K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+4K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+4K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200512—
+5K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20220—
+5K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20210—
+5K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.20180—
+5K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.20181—
+5K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation20162—
+5K130094Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care20132—
+5K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+5K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp.20100—
+5K090943Abt Glucose Control Solution, Model: 2120089American Biological Technologies, Inc.20090—
+5K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+5K080273AB-Trol and Private Label Glucose Control SolutionFujirebio Diagnostics Texas, Inc.20080—
+5K081915FDTX Glucose Control SolutionFujirebio Diagnostics Texas, Inc.20081—
+5K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+5K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.20075—
+5K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.2006102
+6K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—
+6K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20200—
+6K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation20180—
+6K132511Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc.20131—
+6K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+6K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc.20101—
+6K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc.20104Class I
+6K090854Abt Glucose Control Solution, Model 2120090American Biological Technologies, Inc.20090—
+6K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+6K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+6K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+7K153330FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20160—
+7K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+7K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—
+7K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+7K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—
+7K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc.20102Class I
+7K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+8K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—
+8K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+8K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+8K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—