BEUDAMED
    Product Code: DKG FDA class 1 21 CFR 862.2270

    Plate, Cellulose, Tlc

    Clinical Chemistry

    The Cellulose TLC Plate is a thin layer chromatography plate coated with cellulose used as a stationary phase for separating compounds in biological or chemical specimens, supporting clinical chemistry and toxicology laboratory analyses. It is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification. The device is regulated under 21 CFR 862.2270 within the Clinical Chemistry specialty.

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

    Basic Information

    Product Code
    DKG
    Device Class
    FDA class 1
    Regulation Number
    862.2270
    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
    K894327 EMIT D.A.U. LOW & MEDIUM CALIBRATOR A