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

    MICROSCAN MICROSTEP

    K Number: K111394 · Decision Jun 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    49
    Applicant Total
    152
    Review Days
    35

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    Basic Information

    Device Name
    MICROSCAN MICROSTEP
    K Number
    K111394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    May 18, 2011
    Decision Date
    June 22, 2011
    Product Code
    LTT
    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
    LTT Panels, Test, Susceptibility, Antimicrobial

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