BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Cholestech LDX ™ System

    K Number: K223179 · Decision Sep 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    1
    Review Days
    344

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    Basic Information

    Device Name
    Cholestech LDX ™ System
    K Number
    K223179
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alere San Diego, Inc.
    Date Received
    October 11, 2022
    Decision Date
    September 20, 2023
    Product Code
    CGA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CGA Glucose Oxidase, Glucose

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