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

    COBAS REAGENTS FOR GENTAMICIN & CALIBRAT

    K Number: K843827 · Decision Feb 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    296
    Review Days
    126

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    Basic Information

    Device Name
    COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
    K Number
    K843827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    September 28, 1984
    Decision Date
    February 1, 1985
    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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