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510(k) Data Aggregation

    K Number
    K991664
    Device Name
    LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-08-19

    (97 days)

    Product Code
    LBS
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This LDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of low-density lipoprotein-cholesterol (LDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary from the FDA for a device named "LDL-CHOLESTEROL." It is a regulatory clearance letter and does not contain information about the acceptance criteria, study details, or performance metrics of the device.

    Therefore, I cannot provide the requested information based on the given input. The document confirms the device is substantially equivalent to legally marketed predicate devices, but it does not describe the specific studies or data that led to this determination.

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