LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991665
    Device Name
    HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-08-10

    (88 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 :

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

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

    This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) 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

    This document is a 510(k) clearance letter from the FDA for a device named "HDL-CHOLESTEROL." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.

    Therefore, I cannot provide the requested information from this document. The letter focuses on regulatory approval based on substantial equivalence, not on the results of a performance study with detailed acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1