BEUDAMED
    Product Code: DKK FDA class 1 21 CFR 862.2270

    Tanks, Developing, Tlc

    Clinical Chemistry

    TLC Developing Tanks are laboratory apparatus used in thin layer chromatography to provide a controlled environment for solvent migration along TLC plates during compound separation in clinical chemistry and toxicology analyses. 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 862.2270 within the Clinical Chemistry specialty and is exempt from Good Manufacturing Practice (GMP) requirements.

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

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    Basic Information

    Product Code
    DKK
    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
    K812919 MULTI-GRAM DEVELOPING TANK R-12 & R-3