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

    GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK

    K Number: K860031 · Decision Mar 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    13
    Applicant Total
    130
    Review Days
    59

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    Basic Information

    Device Name
    GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
    K Number
    K860031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Organon Teknika Corp.
    Date Received
    January 6, 1986
    Decision Date
    March 6, 1986
    Product Code
    JTT
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTT Susceptibility Test Powders, Antimicrobial

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