BEUDAMED
    Product Code: DJA FDA class 1 21 CFR 862.2250

    Column Supports, Glc

    Clinical Chemistry

    GLC Column Supports are inert packing materials used in gas-liquid chromatography columns to provide a surface for the stationary liquid phase, enabling separation of compounds in laboratory analyses including clinical chemistry and toxicology testing. This device is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification. It is regulated under 21 CFR 862.2250 within the Clinical Chemistry specialty.

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

    Basic Information

    Product Code
    DJA
    Device Class
    FDA class 1
    Regulation Number
    862.2250
    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
    K801833 GAS-CHROMATOGRAPHIC PACKING

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.