BEUDAMED
    Product Code: JHQ FDA class 1 21 CFR 862.1475

    Nephelometric Method, Lipoproteins

    Clinical Chemistry

    Nephelometric Method for Lipoproteins is a clinical chemistry test system that quantifies lipoprotein concentrations using light scattering measurements of antibody-lipoprotein complexes, used in lipid subclass analysis and cardiovascular risk evaluation. It is classified as FDA Class 1 (lowest risk), governed solely by general controls including proper labeling and manufacturing compliance. The product code is JHQ, 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
    —

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    Basic Information

    Product Code
    JHQ
    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
    K802451 BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.