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

    EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640

    K Number: K871329 · Decision May 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    36
    Applicant Total
    288
    Review Days
    39

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    Basic Information

    Device Name
    EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
    K Number
    K871329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    April 3, 1987
    Decision Date
    May 12, 1987
    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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