Product Code: CEM
FDA class 2
21 CFR 862.1600
Electrode, Ion Specific, Potassium
Clinical Chemistry
The Ion-Specific Electrode Potassium Test is a clinical chemistry device that measures potassium ion concentration in blood or other biological fluids using a potassium-selective electrode, providing a rapid and accurate means of assessing electrolyte status, used in the management of cardiac arrhythmias, renal disease, and fluid-electrolyte disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEM, regulated under 21 CFR 862.1600, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
510(k)s
88
FEI Numbers
88
Registration Numbers
88
Unique Applicants
64
Years Active
48
Basic Information
- Product Code
- CEM
- Device Class
- FDA class 2
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 88 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241037 | ABL90 FLEX PLUS System | Jan 14, 2025 | Substantially Equivalent | Radiometer Medicals ApS |
| K220396 | EasyStat 300 | Sep 26, 2023 | Substantially Equivalent | Medica corporation |
| K230890 | ISE Electrodes | Sep 08, 2023 | Substantially Equivalent | Randox Laboratories Ltd. |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Oct 01, 2020 | Substantially Equivalent | Diamond Diagnostics Inc. |
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | Aug 31, 2012 | Substantially Equivalent | INPECO S.P.A. |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Aug 30, 2012 | Substantially Equivalent | DIAMOND DIAGNOSTICS, INC. |
| K112995 | GEM PREMIER 4000 | May 03, 2012 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K110520 | BIOLIS 12I | Mar 23, 2012 | Substantially Equivalent | TOKYO BOEKI MEDISYS INC. |
| K112412 | AU5800(R) CHEMISTRY ANALYZER | Dec 23, 2011 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K112408 | POLY-CHEM 90 ISE MODULE | Nov 04, 2011 | Substantially Equivalent | POLYMEDCO, INC. |
| K112788 | EASTLYTE NA/K/CA/PH | Oct 20, 2011 | Substantially Equivalent | MEDICA CORP. |
| K092686 | ABL90 FLEX SERIES | Aug 06, 2010 | Substantially Equivalent | RADIOMETER MEDICAL APS |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | Mar 30, 2010 | Substantially Equivalent | EPOCAL, INC. |
| K093318 | ACCELERATOR APS | Feb 19, 2010 | Substantially Equivalent | ABBOTT LABORATORIES |
| K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 | Feb 27, 2009 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | Dec 07, 2007 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | Aug 08, 2006 | Substantially Equivalent | THERMO ELECTRON OY |
| K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | Aug 04, 2006 | Substantially Equivalent | OSMETECH, INC. |
| K052914 | RX IMOLA | Mar 31, 2006 | Substantially Equivalent | RANDOX LABORATORIES, LTD. |
| K060373 | COBAS 6000 SERIES SYSTEM | Mar 13, 2006 | Substantially Equivalent | Roche Diagnostics |
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | Nov 12, 2004 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K040750 | BIO-CHEM ANALYZER, MODEL 100 | Oct 28, 2004 | Substantially Equivalent | CLINICAL ANALYSIS CORPORATION, INC. |
| K042270 | STAT K IN VITRO DIAGNOSTIC TEST SYSTEM | Oct 06, 2004 | Substantially Equivalent | STAT CHEM, INC. |
| K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER | Oct 17, 2003 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K013373 | OMNI C ANALYZER | Nov 02, 2001 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K010061 | DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND | Mar 14, 2001 | Substantially Equivalent | DADE BEHRING, INC. |
| K993083 | ALCYON 300I (WITH ISE MODULE) ANALYZER | Oct 05, 1999 | Substantially Equivalent | ABBOTT LABORATORIES |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | Feb 24, 1998 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | Apr 14, 1997 | Substantially Equivalent | DADE INTL., INC. |
| K961326 | EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER | Jun 21, 1996 | Substantially Equivalent | MEDICA CORP. |
| K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) | May 07, 1996 | Substantially Equivalent | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
| K932044 | DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD | Jul 27, 1993 | Substantially Equivalent | DUPONT MEDICAL PRODUCTS |
| K922943 | NOVA NA/K/CL/LI MODULE | Oct 13, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K923038 | MILES POTASSIUM METHOD | Aug 24, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K915345 | STAT K SYSTEM | Jul 16, 1992 | Substantially Equivalent | PORTABLE DIAGNOSTIC SERVICES, INC. |
| K915178 | NOVA 11 NA/K/LI ANALYZER | Jan 27, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K915177 | NOVA 5 NA/K/C1 ALALYZER | Jan 27, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K912649 | ISE/K+ | Jul 15, 1991 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K900788 | MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER | Jul 05, 1990 | Substantially Equivalent | DATACHEM, INC. |
| K901039 | IONOMETER EH | Jun 28, 1990 | Substantially Equivalent | FRESENIUS USA, INC. |
| K901041 | IONOMETER EH-HK AND ACCESSORIES | Jun 18, 1990 | Substantially Equivalent | FRESENIUS USA, INC. |
| K900300 | LYTENING 2Z LYTENING SYSTEM 31 | Mar 01, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K897110 | SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM | Feb 27, 1990 | Substantially Equivalent | MEDISENSE, INC. |
| K896692 | AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER | Jan 02, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K895664 | TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD | Nov 14, 1989 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K890792 | POTASSIUM AND SODIUM ELECTROLYTE ANALYZER | May 03, 1989 | Substantially Equivalent | IONETICS, INC. |
| K884769 | MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY | Jan 17, 1989 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K884566 | VISION LYTE (TM) POTASSIUM | Dec 02, 1988 | Substantially Equivalent | ABBOTT LABORATORIES |
| K883240 | AVL MODEL 986 ELECTROLYTE ANALYZER | Sep 22, 1988 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K870657 | AVL MODEL 985 ELECTROLYTE ANALYZER | May 12, 1987 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K870033 | AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 | Jan 21, 1987 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 05, 1986 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K854298 | IRON | Nov 12, 1985 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K853068 | ILEX PROMPT CLINICAL CHEMISTRY ANALYER | Oct 31, 1985 | Substantially Equivalent | ILEX CORP. |
| K853531 | ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER | Sep 04, 1985 | Substantially Equivalent | AMERICAN DADE |
| K853356 | SERA-210 ELECTROLYTE ANALYZER | Sep 03, 1985 | Substantially Equivalent | HORIBA INSTRUMENTS, INC. |
| K850950 | VISION POTASSIUM | Aug 12, 1985 | Substantially Equivalent | ABBOTT LABORATORIES |
| K851100 | CHEM PRO 1000 CHEMISTRY ANALYSIS | Jul 09, 1985 | Substantially Equivalent | SEN TECH MEDICAL CORP. |
| K851808 | ELECTROLYTE ANALYZER | Jun 25, 1985 | Substantially Equivalent | IONETICS, INC. |
| K851350 | ION 2 REAGENT KI | Apr 29, 1985 | Substantially Equivalent | HI CHEM, INC. |
| K844955 | SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & | Mar 19, 1985 | Substantially Equivalent | MILES LABORATORIES, INC. |
| K844806 | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 | Jan 08, 1985 | Substantially Equivalent | HORIBA INSTRUMENTS, INC. |
| K844044 | LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER | Nov 27, 1984 | Substantially Equivalent | MEDICA CORP. |
| K843454 | ULTRA LYTE POTASSIUM REAGENT KIT | Nov 27, 1984 | Substantially Equivalent | ULTRA QUEST DIAGNOSTICS, INC. |
| K843239 | DACOS PLUS LYTES OPTION | Oct 17, 1984 | Substantially Equivalent | COULTER ELECTRONICS, INC. |
| K842786 | DYNA-LYTE 2000 | Sep 14, 1984 | Substantially Equivalent | ABBOTT DIAGNOSTICS |
| K843008 | ION SELECTIVE ELECTRODES & REAGENT SYS | Sep 04, 1984 | Substantially Equivalent | AMERICAN MONITOR CORP. |
| K840961 | ESCHWEILER COMBI-ANALYSER MTA-500 | Aug 10, 1984 | Substantially Equivalent | U.S. SCIENCE, INC. |
| K842315 | ULTRA LYTE ANALYZER I 100 | Aug 02, 1984 | Substantially Equivalent | ULTRA QUEST DIAGNOSTICS, INC. |
| K841575 | SENTECH'S ULAB 1000 CLINICAL CHEM. | Jul 06, 1984 | Substantially Equivalent | SENTECH MEDICAL CORP. |
| K840887 | AMRESCO E2A REAGENT SET 0562 & 0626 | Apr 18, 1984 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K833696 | ACID BASE LABORATORY ABL4 | Jan 18, 1984 | Substantially Equivalent | RADIOMETER AMERICA, INC. |
| K833776 | QEA SODIUM/POTASSIUM ANALYZER | Dec 29, 1983 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K833159 | POTASSIUM ELECTRODE TIP ASSAMBLY-K- | Nov 25, 1983 | Substantially Equivalent | HI CHEM, INC. |
| K832036 | QEA SODIUM/POTASSIUM ANALYZER | Jul 18, 1983 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K830104 | SERUM IRON DIAGNOSTIC TEST KITS | Jan 28, 1983 | Substantially Equivalent | SCLAVO, INC. |
| K822441 | UNIMETER 330K | Oct 08, 1982 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K821822 | MODEL 1020 NA/K ANALYZER | Jul 02, 1982 | Substantially Equivalent | THERMO ORION |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | Jul 10, 1981 | Substantially Equivalent | CHEM-ELEC, INC. |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | Oct 10, 1980 | Substantially Equivalent | PANMED, INC. |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | May 28, 1980 | Substantially Equivalent | DIAGNOSTIC SOLUTIONS, INC. |
| K800054 | KODAK EKTACHEM ELECTROLYTE ANALYZER | Feb 05, 1980 | Substantially Equivalent | EASTMAN KODAK COMPANY |
| K800016 | DUPONT ACA ION SELECTIVE ELECTRODE | Jan 21, 1980 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K791692 | SODIUM/POTASSIUM BUFFER SOLUTION | Sep 17, 1979 | Substantially Equivalent | HI CHEM, INC. |
| K791175 | ANALYZER, SODIUM/POTASSIUM | Aug 10, 1979 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K790018 | SERUM, POTASSIUM DETERMINATION OF | Feb 01, 1979 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K771837 | POTASSIUM | Nov 02, 1977 | Substantially Equivalent | GAMMA ENTERPRISES, INC. |
| K771118 | CENTRIA SEPARATION COLUMNS TYPE A | Jul 11, 1977 | Substantially Equivalent | CLINICAL DIAGNOSTICS, INC. |
FEI Numbers
This FDA classification entry is associated with 88 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 88 registration numbers. Click on an entry to view related FDA registrations.