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

    GENTAMICIN FLUORESCENT IMMUNOASSAY

    K Number: K813539 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    39
    Review Days
    10

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    Basic Information

    Device Name
    GENTAMICIN FLUORESCENT IMMUNOASSAY
    K Number
    K813539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    December 21, 1981
    Decision Date
    December 31, 1981
    Product Code
    LCQ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCQ Fluorescent Immunoassay Gentamicin

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