BEUDAMED
    Product Code: CGZ FDA class 2 21 CFR 862.1170

    Electrode, Ion-Specific, Chloride

    Clinical Chemistry

    The Electrode, Ion-Specific, Chloride test system (product code CGZ) is an in-vitro diagnostic device used in clinical chemistry to measure chloride ion concentrations in serum, plasma, or urine using an ion-specific electrode, supporting the evaluation of electrolyte balance and acid-base disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1170 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    View on FDA
    510(k)s
    38
    FEI Numbers
    84
    Registration Numbers
    84
    Unique Applicants
    26
    Years Active
    39

    Basic Information

    Product Code
    CGZ
    Device Class
    FDA class 2
    Regulation Number
    862.1170
    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 38 510(k) clearances via K numbers.

    K Number Device Name
    K182072 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
    K170320 Alinity c ICT Sample Diluent
    K162020 VITROS Chemistry Products Cl- Slides
    K082099 VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
    K070889 AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
    K070531 ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
    K060108 COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
    K052027 OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
    K020148 pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
    K013451 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
    K003664 DELFIA NEONATAL IRT KIT, MODEL A005-110
    K003668 AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
    K993697 DELFIA NEONATAL IRT KIT
    K000926 EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
    K991870 ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    K981270 IRMA BLOOD ANALYSIS SYSTEM
    K980757 ILAB 600 CLINICAL CHEMISTRY SYSTEM
    K980367 AEROSET SYSTEM
    K973742 SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
    K972004 ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
    K962479 SYNERMED ISE REAGENTS
    K963992 CAPILLARY ADAPTOR ACCESSORY
    K963734 ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
    K953862 HICHEM ISEKCI SOLUTION KIT 70010
    K953861 HICHEM ISE INTDERNAL REFERENCE KIT 70009
    K953860 HICHEM ISE DILUENT KIT 70008
    K935228 MODEL 644 SWEAT DILUENT
    K924864 NOVA 13 ANALYZER, MODIFICATION
    K912561 NOVA 13 ANALYZER
    K912647 ISE/CI-
    K900887 ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
    K893628 OLYMPUS ISE MODULE FOR AU5000
    K885193 OLYMPUS ISE MODULE
    K863395 WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
    K861669 SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
    K860668 ION-SPECIFIC ELECTRODE, CHLORIDE
    K844021 ISE REAGENTS FOR DEMAND ANALYZER
    K790653 NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER

    FEI Numbers

    This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.