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

    AXSYM TOBRAMYCIN

    K Number: K941614 · Decision Aug 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    883
    Review Days
    136

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    Basic Information

    Device Name
    AXSYM TOBRAMYCIN
    K Number
    K941614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Laboratories
    Date Received
    April 4, 1994
    Decision Date
    August 18, 1994
    Product Code
    LFW
    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
    LFW Fluorescence Polarization Immunoassay, Tobramycin

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