BEUDAMED
    Product Code: DNH FDA class 1 21 CFR 862.2260

    Resins, Ion-Exchange, Liquid Chromatography

    Clinical Chemistry

    Ion-Exchange Resins for Liquid Chromatography are laboratory materials used as stationary phase packing in liquid chromatography columns, enabling ion-exchange-based separation of analytes in clinical chemistry applications. They are a Class 1 device subject to general controls only, with no premarket notification required. The product code is DNH, regulated under 21 CFR 862.2260, within the Clinical Chemistry specialty. No special regulatory flags apply.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    DNH
    Device Class
    FDA class 1
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    4

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K832199 HC40/HC75 CATION EXCHANGE RESIN