Electrode, Ion Specific, Potassium

FDA product code CEM · 89 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1600
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-11 – 2026-02-12

CEM 2026-02-12

ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

Applicant Roche Diagnostics

K number K253491

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CEM 2025-01-14

ABL90 FLEX PLUS System

Applicant Radiometer Medicals Aps

K number K241037

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CEM 2023-09-26

EasyStat 300

Applicant Medica Corporation

K number K220396

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CEM 2023-09-08

ISE Electrodes

Applicant Randox Laboratories, Ltd.

K number K230890

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CEM 2020-10-01

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

Applicant Diamond Diagnostics, Inc.

K number K200544

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CEM 2012-08-31

FLEXLAB 3.6, ACCELERATOR A3600

Applicant Inpeco S.P.A.

K number K121012

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CEM 2012-08-30

SMARTLYTE ELECTROLYTE ANALYZER

Applicant Diamond Diagnostics, Inc.

K number K121040

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CEM 2012-05-03

GEM PREMIER 4000

Applicant Instrumentation Laboratory CO

K number K112995

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CEM 2012-03-23

BIOLIS 12I

Applicant Tokyo Boeki Medisys, Inc.

K number K110520

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CEM 2011-12-23

AU5800(R) CHEMISTRY ANALYZER

Applicant Beckman Coulter, Inc.

K number K112412

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CEM 2011-11-04

POLY-CHEM 90 ISE MODULE

Applicant Polymedco, Inc.

K number K112408

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CEM 2011-10-20

EASTLYTE NA/K/CA/PH

Applicant Medica Corp.

K number K112788

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CEM 2010-08-06

ABL90 FLEX SERIES

Applicant Radiometer Medical Aps

K number K092686

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CEM 2010-03-30

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

Applicant Epocal, Inc.

K number K092849

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CEM 2010-02-19

ACCELERATOR APS

Applicant Abbott Laboratories

K number K093318

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CEM 2009-02-27

VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

Applicant Ortho-Clinical Diagnostics, Inc.

K number K083680

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CEM 2007-12-07

VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2

Applicant Ortho-Clinical Diagnostics, Inc.

K number K073157

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CEM 2006-08-08

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247

Applicant Thermo Electron OY

K number K061107

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CEM 2006-08-04

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

Applicant Osmetech, Inc.

K number K061730

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CEM 2006-03-31

RX IMOLA

Applicant Randox Laboratories, Ltd.

K number K052914

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CEM 2006-03-13

COBAS 6000 SERIES SYSTEM

Applicant Roche Diagnostics

K number K060373

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CEM 2004-11-12

UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

Applicant Beckman Coulter, Inc.

K number K042291

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CEM 2004-10-28

BIO-CHEM ANALYZER, MODEL 100

Applicant Clinical Analysis Corporation, Inc.

K number K040750

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CEM 2004-10-06

STAT K IN VITRO DIAGNOSTIC TEST SYSTEM

Applicant Stat Chem, Inc.

K number K042270

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CEM 2003-10-17

ROCHE DIAGNOSTICS OMNI S ANALYZER

Applicant Roche Diagnostics Corp.

K number K032311

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CEM 2001-11-02

OMNI C ANALYZER

Applicant Roche Diagnostics Corp.

K number K013373

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CEM 2001-03-14

DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND

Applicant Dade Behring, Inc.

K number K010061

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CEM 1999-10-05

ALCYON 300I (WITH ISE MODULE) ANALYZER

Applicant Abbott Laboratories

K number K993083

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CEM 1998-02-24

AVL OPTI CRITICAL CARE ANALYZER

Applicant Avl Scientific Corp.

K number K974784

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CEM 1997-04-14

DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE

Applicant Dade Intl., Inc.

K number K970330

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CEM 1996-06-21

EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER

Applicant Medica Corp.

K number K961326

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CEM 1996-05-07

EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K961115

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CEM 1993-07-27

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD

Applicant Dupont Medical Products

K number K932044

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CEM 1992-10-13

NOVA NA/K/CL/LI MODULE

Applicant Nova Biomedical Corp.

K number K922943

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CEM 1992-08-24

MILES POTASSIUM METHOD

Applicant Heraeus Kulzer, Inc.

K number K923038

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CEM 1992-07-16

STAT K SYSTEM

Applicant Portable Diagnostic Services, Inc.

K number K915345

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CEM 1992-01-27

NOVA 11 NA/K/LI ANALYZER

Applicant Nova Biomedical Corp.

K number K915178

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CEM 1992-01-27

NOVA 5 NA/K/C1 ALALYZER

Applicant Nova Biomedical Corp.

K number K915177

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CEM 1991-07-15

ISE/K+

Applicant Boehringer Mannheim Corp.

K number K912649

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CEM 1990-07-05

MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER

Applicant Datachem, Inc.

K number K900788

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CEM 1990-06-28

IONOMETER EH

Applicant Fresenius USA, Inc.

K number K901039

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CEM 1990-06-18

IONOMETER EH-HK AND ACCESSORIES

Applicant Fresenius USA, Inc.

K number K901041

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CEM 1990-03-01

LYTENING 2Z LYTENING SYSTEM 31

Applicant Baxter Healthcare Corp

K number K900300

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CEM 1990-02-27

SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM

Applicant Medisense, Inc.

K number K897110

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CEM 1990-01-02

AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER

Applicant Baxter Healthcare Corp

K number K896692

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CEM 1989-11-14

TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD

Applicant Technicon Instruments Corp.

K number K895664

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CEM 1989-05-03

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER

Applicant Ionetics, Inc.

K number K890792

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CEM 1989-01-17

MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY

Applicant Ciba Corning Diagnostics Corp.

K number K884769

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CEM 1988-12-02

VISION LYTE (TM) POTASSIUM

Applicant Abbott Laboratories

K number K884566

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CEM 1988-09-22

AVL MODEL 986 ELECTROLYTE ANALYZER

Applicant Avl Scientific Corp.

K number K883240

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CEM 1987-05-12

AVL MODEL 985 ELECTROLYTE ANALYZER

Applicant Avl Scientific Corp.

K number K870657

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CEM 1987-01-21

AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460

Applicant American Research Products Co.

K number K870033

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CEM 1986-03-05

SKD ELECTROCHEMICAL SYSTEM (ECS)

Applicant Smithkline Diagnostics, Inc.

K number K854723

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CEM 1985-11-12

IRON

Applicant Boehringer Mannheim Corp.

K number K854298

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CEM 1985-10-31

ILEX PROMPT CLINICAL CHEMISTRY ANALYER

Applicant Ilex Corp.

K number K853068

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CEM 1985-09-04

ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER

Applicant American Dade

K number K853531

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CEM 1985-09-03

SERA-210 ELECTROLYTE ANALYZER

Applicant Horiba Instruments, Inc.

K number K853356

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CEM 1985-08-12

VISION POTASSIUM

Applicant Abbott Laboratories

K number K850950

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CEM 1985-07-09

CHEM PRO 1000 CHEMISTRY ANALYSIS

Applicant Sen Tech Medical Corp.

K number K851100

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CEM 1985-06-25

ELECTROLYTE ANALYZER

Applicant Ionetics, Inc.

K number K851808

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CEM 1985-04-29

ION 2 REAGENT KI

Applicant Hi Chem, Inc.

K number K851350

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CEM 1985-03-19

SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &

Applicant Miles Laboratories, Inc.

K number K844955

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CEM 1985-01-08

MODIFY ELECTROLYTE ANALYZER MODEL SERA-210

Applicant Horiba Instruments, Inc.

K number K844806

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CEM 1984-11-27

LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER

Applicant Medica Corp.

K number K844044

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CEM 1984-11-27

ULTRA LYTE POTASSIUM REAGENT KIT

Applicant Ultra Quest Diagnostics, Inc.

K number K843454

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CEM 1984-10-17

DACOS PLUS LYTES OPTION

Applicant Coulter Electronics, Inc.

K number K843239

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CEM 1984-09-14

DYNA-LYTE 2000

Applicant Abbott Diagnostics

K number K842786

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CEM 1984-09-04

ION SELECTIVE ELECTRODES & REAGENT SYS

Applicant American Monitor Corp.

K number K843008

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CEM 1984-08-10

ESCHWEILER COMBI-ANALYSER MTA-500

Applicant U.S. Science, Inc.

K number K840961

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CEM 1984-08-02

ULTRA LYTE ANALYZER I 100

Applicant Ultra Quest Diagnostics, Inc.

K number K842315

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CEM 1984-07-06

SENTECH'S ULAB 1000 CLINICAL CHEM.

Applicant Sen Tech Medical Corp.

K number K841575

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CEM 1984-04-18

AMRESCO E2A REAGENT SET 0562 & 0626

Applicant American Research Products Co.

K number K840887

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CEM 1984-01-18

ACID BASE LABORATORY ABL4

Applicant Radiometer America, Inc.

K number K833696

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CEM 1983-12-29

QEA SODIUM/POTASSIUM ANALYZER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K833776

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CEM 1983-11-25

POTASSIUM ELECTRODE TIP ASSAMBLY-K-

Applicant Hi Chem, Inc.

K number K833159

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CEM 1983-07-18

QEA SODIUM/POTASSIUM ANALYZER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K832036

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CEM 1983-01-28

SERUM IRON DIAGNOSTIC TEST KITS

Applicant Sclavo, Inc.

K number K830104

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CEM 1982-10-08

UNIMETER 330K

Applicant Boehringer Mannheim Corp.

K number K822441

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CEM 1982-07-02

MODEL 1020 NA/K ANALYZER

Applicant Thermo Orion

K number K821822

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CEM 1981-07-10

SODIUM/POTASSIUM REAGENT KITS

Applicant Chem-Elec, Inc.

K number K811310

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CEM 1980-10-10

POSTASSIUM BUFFER SOL. & WASH SOLUTION

Applicant Panmed, Inc.

K number K802158

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CEM 1980-05-28

REAGENT FOR DETERM. POTASSIUM/IN HUMAN

Applicant Diagnostic Solutions, Inc.

K number K800692

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CEM 1980-02-05

KODAK EKTACHEM ELECTROLYTE ANALYZER

Applicant Eastman Kodak Company

K number K800054

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CEM 1980-01-21

DUPONT ACA ION SELECTIVE ELECTRODE

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K800016

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CEM 1979-09-17

SODIUM/POTASSIUM BUFFER SOLUTION

Applicant Hi Chem, Inc.

K number K791692

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CEM 1979-08-10

ANALYZER, SODIUM/POTASSIUM

Applicant Nova Biomedical Corp.

K number K791175

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CEM 1979-02-01

SERUM, POTASSIUM DETERMINATION OF

Applicant Fisher Scientific Co., LLC

K number K790018

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CEM 1977-11-02

POTASSIUM

Applicant Gamma Enterprises, Inc.

K number K771837

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CEM 1977-07-11

CENTRIA SEPARATION COLUMNS TYPE A

Applicant Clinical Diagnostics, Inc.

K number K771118

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