BEUDAMED
    Product Code: PYP FDA class 1 21 CFR 862.1475

    Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

    Clinical Chemistry

    The Low-Density Lipoprotein (LDL) Cholesterol Sub-Fraction Test is an in vitro diagnostic device intended for the quantitative determination of low-density lipoprotein cholesterol sub-fractions in human specimens, used in the assessment of cardiovascular risk. It is classified as a Class 1 device under regulation 862.1475, subject to general controls and eligible for third-party 510(k) review. The product code is PYP, and it falls within the Clinical Chemistry (CH) medical specialty. It is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    PYP
    Device Class
    FDA class 1
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K161679 s LDL-EX SEIKEN

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.