Electrode, Ion Specific, Sodium

FDA product code JGS · 160 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1665
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-14 – 2026-05-01

JGS 2026-05-01

ABL90 FLEX PLUS System

Applicant Radiometer Medicals Aps

K number K252475

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JGS 2023-10-27

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

Applicant Abbott Point of Care, Inc.

K number K230275

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JGS 2023-07-25

A-LYTE® Integrated Multisensor (IMT Na K Cl)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K222438

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JGS 2023-07-20

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

Applicant Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

K number K220977

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JGS 2022-03-10

GLP systems Track

Applicant Abbott Laboratories

K number K213486

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JGS 2020-04-14

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K number K200403

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JGS 2020-02-07

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

Applicant Abbott Point of Care, Inc.

K number K183688

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JGS 2019-07-19

Stat Profile Prime ES Comp Plus Analyzer System

Applicant Nova Biomedical Corporation

K number K191365

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JGS 2019-06-12

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

Applicant Ams Diagnostics

K number K172232

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JGS 2019-02-16

GEM Premier ChemSTAT

Applicant Instrumentation Laboratory CO

K number K183549

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JGS 2018-08-15

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K number K180428

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JGS 2018-07-10

Synermed ISE Reagents

Applicant Infrared Laboratory Systems, LLC (Dba Synermed)

K number K181201

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JGS 2018-02-27

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

Applicant Awareness Technology, Inc.

K number K171476

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JGS 2017-03-09

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

Applicant Siemens Healthcare Diagnostics

K number K161954

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JGS 2016-12-16

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

Applicant Beckman Coulter, Inc.

K number K161837

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JGS 2016-12-14

GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator

Applicant Instrumentation Laboratory CO

K number K160225

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JGS 2016-07-08

i-STAT Alinity System with i-STAT Sodium test

Applicant Abbott Point of Care, Inc.

K number K153357

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JGS 2016-06-09

BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K160370

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JGS 2013-12-18

COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2

Applicant Roche Diagnostics

K number K132418

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JGS 2013-05-21

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

Applicant Roche Diagnostics

K number K123726

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JGS 2012-08-22

PROLYTE ELECTROLYTE ANALYZER

Applicant Diamond Diagnostics, Inc.

K number K121140

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JGS 2011-03-24

ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...

Applicant Elitechgroup Vital Scientific BV

K number K102647

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JGS 2011-01-14

PROLYTE ELECTROLYTE ANALYZER

Applicant Diamond Diagnostics, Inc.

K number K102959

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JGS 2011-01-14

EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

Applicant Medica Corp.

K number K100829

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JGS 2010-04-06

EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

Applicant Medica Corp.

K number K100673

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JGS 2009-09-03

VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927

Applicant Ortho-Clinical Diagnostics, Inc.

K number K091861

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JGS 2009-02-06

GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+

Applicant Diamond Diagnostics, Inc.

K number K082462

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JGS 2008-06-30

VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

Applicant Ortho-Clinical Diagnostics, Inc.

K number K081411

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JGS 2008-05-07

PROLYTE ELECTROLYTE ANALYZER

Applicant Diamond Diagnostics, Inc.

K number K070104

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JGS 2006-09-27

EPOC BLOOD ANALYSIS SYSTEM

Applicant Epocal, Inc.

K number K061597

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JGS 2006-01-13

Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

Applicant I-Stat Corporation

K number K053110

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JGS 2005-12-14

ISE INDIRECT NA, K, CL FOR GEN.2

Applicant Roche Diagnostics Corp.

K number K053165

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JGS 2005-12-14

TECO ISE REAGENT SET FOR CX SYSTEM

Applicant Teco Diagnostics

K number K052724

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JGS 2005-10-07

ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

Applicant Pointe Scientific, Inc.,

K number K051646

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JGS 2004-12-27

GENCHEM ELECTROLYTE BUFFER

Applicant Genchem, Inc.

K number K040977

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JGS 2004-12-22

GENCHEM ISE ELECTROLYTE REFERENCE

Applicant Genchem, Inc.

K number K040971

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JGS 2002-10-04

SYNCHRON LX I 725 CLINICAL SYSTEM

Applicant Beckman Coulter, Inc.

K number K023049

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JGS 2002-06-04

PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS

Applicant Phoenix Diagnostics, Inc.

K number K020364

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JGS 2001-05-16

MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

Applicant Beckman Coulter, Inc.

K number K011213

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JGS 2001-02-02

EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER

Applicant Medica Corp.

K number K002407

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JGS 2000-10-12

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER

Applicant Biocare Corp.

K number K002855

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JGS 2000-08-07

STATLYTE NA/K/CL/LI ANALYZER

Applicant Nova Biomedical Corp.

K number K001761

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JGS 2000-04-18

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

Applicant I-Stat Corp.

K number K001154

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JGS 2000-04-17

STAT PROFILE PHOX PLUS ANALYZER

Applicant Nova Biomedical Corp.

K number K000895

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JGS 1999-11-26

HICHEM ISE ELECTROLYTE BUFFER

Applicant Elan Holdings, Inc.

K number K992844

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JGS 1999-11-26

HICHEM ISE ELECTROLYTE REFERENCE

Applicant Elan Holdings, Inc.

K number K992842

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JGS 1999-10-25

PICCOLO SODIUM TEST SYSTEM

Applicant Abaxis, Inc.

K number K993211

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JGS 1999-05-21

BAYER ADVIA 1650 CHEMISTRY SYSTEM

Applicant Bayer Corp.

K number K990346

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JGS 1999-03-18

CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000

Applicant Careside, Inc.

K number K990036

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JGS 1996-11-29

EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER

Applicant Medica Corp.

K number K963763

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JGS 1996-10-24

(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE

Applicant Roche Diagnostic Systems, Inc.

K number K963627

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JGS 1996-10-24

EML105 ELECTROLYTE METABOLITE ANALYZER

Applicant Radiometer America, Inc.

K number K962334

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JGS 1996-09-27

SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT

Applicant Sigma Diagnostics, Inc.

K number K963542

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JGS 1996-05-07

EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K961099

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JGS 1996-02-23

EASYSTAT SODIUM/POTASSIUM ANALYZER

Applicant Medica Corp.

K number K955375

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JGS 1996-02-23

EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER

Applicant Medica Corp.

K number K955374

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JGS 1995-06-20

SYNERMED ISE REAGENTS

Applicant Synermed, Inc.

K number K952179

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JGS 1994-04-26

SYNERMED ISE REAGENTS

Applicant Synermed, Inc.

K number K941400

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JGS 1994-04-26

EML 100

Applicant Radiometer America, Inc.

K number K935120

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JGS 1994-04-05

SYNERMED ISE REAGENTS

Applicant Synermed, Inc.

K number K940194

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JGS 1993-11-17

MODEL 400/450 ELECTROLYTE ANALYZER

Applicant Ionetics, Inc.

K number K932179

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JGS 1993-10-12

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)

Applicant Schiapparelli Biosystems, Inc.

K number K933862

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JGS 1993-08-19

CIBA CORNING 300 SERIES SYSTEM

Applicant Ciba Corning Diagnostics Corp.

K number K933373

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JGS 1993-04-20

HI CHEM ELECTROLYTE BUFFER

Applicant Hichem Diagnostics

K number K925612

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JGS 1993-02-23

HI CHEM ELECTROLYTE REFERENCE REAGENT

Applicant Hichem Diagnostics

K number K925611

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JGS 1993-01-28

NOVA 8 CRT ANALYZER

Applicant Nova Biomedical Corp.

K number K924547

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JGS 1992-11-06

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)

Applicant Eastman Kodak Company

K number K924471

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JGS 1992-09-29

ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER

Applicant Nova Biomedical Corp.

K number K923806

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JGS 1992-07-27

NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION

Applicant Nova Biomedical Corp.

K number K921937

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JGS 1992-07-21

OLYMPUS ISE MODULE

Applicant Olympus Corp.

K number K921718

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JGS 1992-07-17

NOVA 14 NA/K/CL/GLU/BUN ANALYZER

Applicant Nova Biomedical Corp.

K number K922215

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JGS 1992-01-15

NOVA 4 NA/K/C1/TCO2/LI ANALYZER

Applicant Nova Biomedical Corp.

K number K915176

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JGS 1991-12-04

EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER

Applicant Medica Corp.

K number K914810

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JGS 1991-09-30

MEDISENSOR 2001

Applicant Medtest Systems, Inc.

K number K903564

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JGS 1991-07-17

ISE/NA+

Applicant Boehringer Mannheim Corp.

K number K912648

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JGS 1991-07-17

NOVA 12 ANALYZER

Applicant Nova Biomedical Corp.

K number K912560

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JGS 1991-07-01

NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER

Applicant Nova Biomedical Corp.

K number K912559

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JGS 1991-07-01

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK

Applicant I-Stat Corp.

K number K912387

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JGS 1991-06-10

IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER

Applicant Instrumentation Laboratory CO

K number K912016

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JGS 1991-04-03

GEM-PREMIER SYSTEM

Applicant Mallinckrodt Sensor Systems, Inc.

K number K910305

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JGS 1991-03-06

CLINAK(TM) ISE SUBSYSTEM

Applicant Baxter Healthcare Corp

K number K910554

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JGS 1991-03-05

STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS

Applicant Nova Biomedical Corp.

K number K905264

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JGS 1991-01-15

TECHLYTE ELECTROLYTE ANALYZER

Applicant Technalysis, Inc.

K number K905600

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JGS 1990-10-12

SECONDARY CALIBRATORS

Applicant Bionostics, Inc.

K number K904335

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JGS 1990-09-10

ABBOTT VISION LYTE (TM) SODIUM

Applicant Abbott Laboratories

K number K903188

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JGS 1990-07-31

IONOMETER EF-HK AND ACCESSORIES

Applicant Fresenius USA, Inc.

K number K901042

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JGS 1990-07-19

IONOMETER EH-F AND ACCESSORIES

Applicant Fresenius USA, Inc.

K number K901040

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JGS 1990-01-02

LYTENING(TM) 5, LYTENING(TM) SYSTEM 30

Applicant Baxter Healthcare Corp

K number K896526

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JGS 1989-12-12

EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER

Applicant Medica Corp.

K number K895936

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JGS 1989-10-31

EOS CHEMISTRY ANALYZER

Applicant Eos Technology Corp.

K number K894035

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JGS 1989-10-25

TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD

Applicant Technicon Instruments Corp.

K number K895672

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JGS 1989-10-16

MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK

Applicant I-Stat Corp.

K number K894914

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JGS 1989-09-07

NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM

Applicant Nova Biomedical Corp.

K number K894218

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JGS 1989-07-20

CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE

Applicant Ciba Corning Diagnostics Corp.

K number K892500

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JGS 1988-08-29

RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.

Applicant Hf Scientific, Inc.

K number K882801

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JGS 1988-07-05

ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.

Applicant Paramax Systems Div. Baxter Healthcare

K number K882104

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JGS 1988-07-01

NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT

Applicant Nova Biomedical Corp.

K number K880750

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JGS 1988-05-27

LYTENING 5

Applicant Amdev, Inc.

K number K880917

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JGS 1988-05-16

NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA

Applicant Nova Biomedical Corp.

K number K881255

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JGS 1988-02-11

NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL

Applicant Nova Biomedical Corp.

K number K874832

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