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510(k) Data Aggregation

    K Number
    K022772
    Device Name
    RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-09-17

    (27 days)

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

    RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

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

    This reagent is intended for the quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples. LDL-Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

    Device Description

    RAICHEM® LDL – Cholesterol Direct Reagent

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "RAICHEM® LDL - Cholesterol Direct Reagent." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information from the provided text.

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