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

    CYBREX TOBRAMYCIN

    K Number: K802668 · Decision Nov 24, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    883
    Review Days
    28

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    Basic Information

    Device Name
    CYBREX TOBRAMYCIN
    K Number
    K802668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Abbott Laboratories
    Date Received
    October 27, 1980
    Decision Date
    November 24, 1980
    Product Code
    LCR
    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
    LCR Fluorescent Immunoassay, Tobramycin

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