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

    GENTAMICIN FPIA REAGENT SET AND CALIBRATORS

    K Number: K943550 · Decision Nov 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    164
    Review Days
    119

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    Basic Information

    Device Name
    GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
    K Number
    K943550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    July 21, 1994
    Decision Date
    November 17, 1994
    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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