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

    CEDIA(R) TOBRAMYCIN ASSAY

    K Number: K912143 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    107
    Review Days
    72

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    Basic Information

    Device Name
    CEDIA(R) TOBRAMYCIN ASSAY
    K Number
    K912143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microgenics Corp.
    Date Received
    May 15, 1991
    Decision Date
    July 26, 1991
    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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