Glucose Oxidase, Glucose

CGA 2024-09-30

YSI 2900C Biochemistry Analyzer

Applicant Ysi, Inc.

K number K210933

CGA 2024-07-26

EasyStat 300

Applicant Medica Corporation

K number K220328

CGA 2023-09-20

Cholestech LDX ™ System

Applicant Alere San Diego, Inc.

K number K223179

CGA 2023-09-11

i-STAT G cartridge with the i-STAT 1 System

K number K223755

CGA 2023-07-28

i-STAT CG8+ cartridge with the i-STAT 1 System

K number K223710

CGA 2023-01-27

GEM Premier ChemSTAT

K number K223090

CGA 2022-10-18

Nova Primary Glucose Analyzer System

Applicant Nova Biomedical Corporation

K number K203549

CGA 2021-08-13

i-STAT CHEM8+ cartridge with the i-STAT 1 System

K number K210958

CGA 2020-03-13

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K number K200349

CGA 2020-02-07

i-STAT CHEM8+ cartridge with the i-STAT 1 System

K number K183678

CGA 2019-04-03

VITROS XT Chemistry Products GLU-Ca Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K number K190520

CGA 2019-02-16

GEM Premier ChemSTAT

K number K183546

CGA 2018-12-21

PTS Professional Chemistry Kit

Applicant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K number K182781

CGA 2018-09-26

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K number K180340

CGA 2017-09-18

VITROS Chemistry Products GLU Slides

Applicant Ortho Clinical Diagnostics

K number K163433

CGA 2017-04-10

i-Stat Alinity System with i-Stat Glucose test

K number K163271

CGA 2016-12-22

CardioChek Plus Test System, CardioChek Home Test System

Applicant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K number K162282

CGA 2016-12-14

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)

K number K160402

CGA 2016-09-14

GEM Premier 3000

K number K161818

CGA 2016-06-24

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

Applicant Infrared Laboratory Systems, LLC (Dba Synermed)

K number K153692

CGA 2013-05-15

ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE

Applicant Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen

K number K120615

CGA 2013-03-08

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

Applicant Philosys Co., Ltd.

K number K113636

CGA 2013-01-14

FORA V10 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Foracare, Inc.

K number K121706

CGA 2012-11-21

ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM

Applicant ACON Laboratories, Inc.

K number K122110

CGA 2012-09-05

AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION

Applicant I-Sens, Inc.

K number K121654

CGA 2012-08-21

CLEVER CHOICE

Applicant Simple Diagnostics, Inc.

K number K120921

CGA 2012-06-05

CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION

Applicant I-Sens, Inc.

K number K120759

CGA 2012-05-08

ELEMENT BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K113670

CGA 2012-04-24

AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

Applicant Bestgen Biotech Corp.

K number K103230

CGA 2012-04-06

MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

K number K120448

CGA 2012-03-28

GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL

K number K113547

CGA 2012-03-13

AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

Applicant Bestgen Biotech Corp.

K number K103116

CGA 2012-01-26

GAL-1A BLOOD GLUCOSE MONITORING SYSTEM

K number K113208

CGA 2011-10-28

ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION

Applicant I-Sens, Inc.

K number K103278

CGA 2011-10-07

GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

Applicant Broadmaster Biotech Corporation

K number K102316

CGA 2011-10-06

ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM

Applicant ACON Laboratories, Inc.

K number K111371

CGA 2011-09-16

EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K number K111728

CGA 2011-08-31

MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION

K number K101204

CGA 2011-04-27

UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

Applicant Beckman Coulter, Inc.

K number K103842

CGA 2011-03-16

IVD-GE02

Applicant Sphere Medical , Ltd.

K number K101947

CGA 2011-02-08

I-STAT 1 WIRELESS ANALYZER

K number K103195

CGA 2011-01-25

DIATRON PICTUS 400

Applicant Diatron Group

K number K101741

CGA 2010-12-15

ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

Applicant Seppim S.A.S.

K number K100525

CGA 2010-08-13

AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS

K number K102037

CGA 2010-07-09

FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

K number K100405

CGA 2010-05-11

FORA V20 BLOOD GLUCOSE MONITORING SYSTEM

K number K100406

CGA 2010-05-05

EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT

Applicant Medica Corp.

K number K100187

CGA 2010-04-01

CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267

K number K093506

CGA 2010-03-26

CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265

K number K093941

CGA 2010-03-10

INTEGRATED LABORATORY AUTOMATION SOLUTION

Applicant Integrated Laboratory Automation Solutions, Inc.

K number K091975

CGA 2009-12-07

DS-A BLOOD GLUCOSE MONITORING SYSTEM

Applicant Alliance International Co., Ltd.

K number K082965

CGA 2009-11-24

ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

K number K092104

CGA 2009-11-20

FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE

K number K091814

CGA 2009-10-23

ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS

K number K091102

CGA 2009-06-24

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

Applicant Epocal, Inc.

K number K090109

CGA 2009-04-09

AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9

K number K090043

CGA 2009-03-11

U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM

K number K083570

CGA 2009-02-13

DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100

Applicant Hubdic Co., Ltd.

K number K080636

CGA 2009-01-30

FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254

K number K082482

CGA 2009-01-09

FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245

K number K083664

CGA 2008-10-21

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110

K number K082417

CGA 2008-09-17

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005

K number K082121

CGA 2008-07-25

FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM

K number K081714

CGA 2008-07-02

CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237

K number K081609

CGA 2008-06-13

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM

K number K073416

CGA 2008-04-10

GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1

K number K073648

CGA 2007-08-30

EASYRA CLINICAL CHEMISTRY ANALYZER

Applicant Medica Corp.

K number K070057

CGA 2007-07-13

TRILOGY ANALYZER

Applicant Drew Scientific, Inc.

K number K070704

CGA 2007-07-11

NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM

Applicant Nova Biomedical Corp.

K number K070960

CGA 2007-02-06

GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM

K number K062799

CGA 2007-01-24

NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Applicant Nova Biomedical Corp.

K number K063821

CGA 2007-01-22

EUKARE

Applicant Eumed Biotechnology Co., Ltd.

K number K062892

CGA 2007-01-12

EASYGLUCO, MODEL IGM-0002 G2

Applicant U. S. Diagnostics, Inc.

K number K061431

CGA 2006-09-22

SELFCHECK GLUCO

Applicant Card Guard Scientific Survival , Ltd.

K number K061528

CGA 2006-09-19

EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

K number K061992

CGA 2006-04-28

NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS

Applicant Nova Biomedical Corp.

K number K060345

CGA 2006-03-28

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001

Applicant Hypoguard USA, Inc.

K number K053079

CGA 2006-03-09

ACCUREX GLUCOSE TEST STRIP

Applicant Incline Medical, LLC

K number K052207

CGA 2005-10-21

GEM PREMIER 3000

K number K052121

CGA 2005-08-09

Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM

Applicant Biomedix, Inc.

K number K050182

CGA 2005-08-02

GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM

Applicant Infopia Co, Ltd.

K number K051285

CGA 2005-05-20

ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K043197

CGA 2005-04-29

EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM

K number K043245

CGA 2005-04-08

EASYGLUCO IGM-0002 G2

Applicant American Healthcare, Inc.

K number K043512

CGA 2005-03-25

ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100

Applicant Hypoguard USA, Inc.

K number K041881