ClearanceBrief
Panels › Clinical Chemistry › Product code CGA · Class 2

Glucose Oxidase, Glucose

Regulation 862.1345

1510(k)s in 12 months (401 all time)
0recalls in 12 months (89 all time)
79recalls that name a 510(k)
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Top companies in CGA

Company510(k)sRecalls
Lifescan, Inc.215
Roche Diagnostics Corp.320
Boehringer Mannheim Corp.170
Apex BioTechnology Corp.140
Abbott Point of Care, Inc.66
Miles Laboratories, Inc.120
Nova Biomedical Corp.75
Instrumentation Laboratory CO92
Medisense, Inc.110
Heraeus Kulzer, Inc.100
Decided510(k)Device and applicantCode
May 1, 2026K252488ABL90 FLEX PLUS System
Radiometer Medicals Aps, DK
CGA
Sep 30, 2024K210933YSI 2900C Biochemistry Analyzer
Ysi, Inc.
CGA
Jul 26, 2024K220328EasyStat 300
Medica Corporation
CGA
Sep 20, 2023K223179Cholestech LDX ™ System
Alere San Diego, Inc.
CGA
Sep 11, 2023K223755i-STAT G cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Jul 28, 2023K223710i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Jan 27, 2023K223090GEM Premier ChemSTAT
Instrumentation Laboratory CO
CGA
Oct 18, 2022K203549Nova Primary Glucose Analyzer System
Nova Biomedical Corporation
CGA
Aug 13, 2021K210958i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Mar 13, 2020K200349Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
CGA
Feb 7, 2020K183678i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Apr 3, 2019K190520VITROS XT Chemistry Products GLU-Ca Slides
Ortho-Clinical Diagnostics, Inc.
CGA
Feb 16, 2019K183546GEM Premier ChemSTAT
Instrumentation Laboratory CO
CGA
Dec 21, 2018K182781PTS Professional Chemistry Kit
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
CGA
Sep 26, 2018K180340Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
CGA
Sep 18, 2017K163433VITROS Chemistry Products GLU Slides
Ortho Clinical Diagnostics
CGA
Apr 10, 2017K163271i-Stat Alinity System with i-Stat Glucose test
Abbott Point of Care, Inc.
CGA
Dec 22, 2016K162282CardioChek Plus Test System, CardioChek Home Test System
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
CGA
Dec 14, 2016K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
Instrumentation Laboratory CO
CGA
Sep 14, 2016K161818GEM Premier 3000
Instrumentation Laboratory CO
CGA
Jun 24, 2016K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
Infrared Laboratory Systems, LLC (Dba Synermed)
CGA
Dec 7, 2015K151639ABL80 FLEX and ABL80 FLEX CO-OX
Sendx Medical, Inc.
CGA
Aug 6, 2015K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
Apex BioTechnology Corp., TW
CGA
Jul 7, 2015K151530CardioChek Plus Test System
Polymer Technology Systems, Inc.
CGA
May 7, 2015K143750MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
Apex BioTechnology Corp., TW
CGA
Oct 2, 2014K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANE
Polymer Technology Systems, Inc.
CGA
Sep 17, 2014K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
Arkray Factory, Inc., JP
CGA
Sep 8, 2014K133584IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
Eoshealth, Inc.
CGA
Jun 30, 2014K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
Arkray Factory, Inc.
CGA
Mar 6, 2014K131750AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
Apex BioTechnology Corp., TW
CGA
May 15, 2013K120615ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen
CGA
Mar 8, 2013K113636BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
Philosys Co., Ltd.
CGA
Jan 14, 2013K121706FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
Foracare, Inc., TW
CGA
Nov 21, 2012K122110ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
ACON Laboratories, Inc.
CGA
Sep 5, 2012K121654AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
I-Sens, Inc., KR
CGA
Aug 21, 2012K120921CLEVER CHOICE
Simple Diagnostics, Inc.
CGA
Jun 5, 2012K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
I-Sens, Inc., KR
CGA
May 8, 2012K113670ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd.
CGA
Apr 24, 2012K103230AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
Bestgen Biotech Corp., TW
CGA
Apr 6, 2012K120448MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
Apex BioTechnology Corp., TW
CGA
Mar 28, 2012K113547GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
Apex BioTechnology Corp., TW
CGA
Mar 13, 2012K103116AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
Bestgen Biotech Corp., TW
CGA
Jan 26, 2012K113208GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
Apex BioTechnology Corp., TW
CGA
Oct 28, 2011K103278ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
I-Sens, Inc., KR
CGA
Oct 7, 2011K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
Broadmaster Biotech Corporation, TW
CGA
Oct 6, 2011K111371ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
ACON Laboratories, Inc.
CGA
Sep 16, 2011K111728EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
CGA
Aug 31, 2011K101204MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
Apex BioTechnology Corp., TW
CGA
Apr 27, 2011K103842UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
Beckman Coulter, Inc.
CGA
Mar 16, 2011K101947IVD-GE02
Sphere Medical , Ltd., GB
CGA

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