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

    VIRGO IPA FOR DETECTION OF GENTAMICIN

    K Number: K811744 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    36
    Applicant Total
    41
    Review Days
    21

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    Basic Information

    Device Name
    VIRGO IPA FOR DETECTION OF GENTAMICIN
    K Number
    K811744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    June 19, 1981
    Decision Date
    July 10, 1981
    Product Code
    LCD
    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
    LCD Enzyme Immunoassay, Gentamicin

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