BEUDAMED
    Product Code: JHL FDA class 1 21 CFR 862.1475

    Microdensitometry Method, Lipoproteins

    Clinical Chemistry

    Microdensitometry Method for Lipoproteins is a clinical chemistry test system using microdensitometric scanning of electrophoretic separations to quantify lipoprotein fractions in serum, supporting lipid profiling and cardiovascular risk assessment. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JHL, regulated under 21 CFR 862.1475, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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

    Basic Information

    Product Code
    JHL
    Device Class
    FDA class 1
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    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
    K770948 LIPOPROTEIN PROFILING SYSTEM