BEUDAMED
    Product Code: MSM FDA class 1 21 CFR 862.1475

    System, Test, Lipoprotein(A)

    Clinical Chemistry

    A Lipoprotein(a) Test System is a laboratory diagnostic device used to measure levels of lipoprotein(a), an independent risk factor for cardiovascular disease, in patient blood or plasma samples. It is FDA Class 1 under general controls with product code MSM, regulated under 21 CFR 862.1475 within the Clinical Chemistry specialty. No premarket submission is required. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MSM
    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

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.