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

    EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

    K Number: K962519 · Decision Sep 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    36
    Applicant Total
    145
    Review Days
    69

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    Basic Information

    Device Name
    EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
    K Number
    K962519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    June 27, 1996
    Decision Date
    September 4, 1996
    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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