BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    hemoFISH Masterpanel

    K Number: K150031 · Decision Oct 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    hemoFISH Masterpanel
    K Number
    K150031
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miacom Diagnostics GmbH
    Date Received
    January 8, 2015
    Decision Date
    October 1, 2015
    Product Code
    JSS
    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
    JSS Kit, Identification, Enterobacteriaceae

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