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

    MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS

    K Number: K131275 · Decision Nov 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    189

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    Basic Information

    Device Name
    MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
    K Number
    K131275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Helathcare Diagnostics, Inc.
    Date Received
    May 3, 2013
    Decision Date
    November 8, 2013
    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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    Other Clearances by Siemens Helathcare Diagnostics, Inc.

    K Number Device Name
    K132391 IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL