BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BD BACTEC Peds Plus/F Culture Vials (plastic)

    K Number: K151866 · Decision Feb 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    2
    Review Days
    231

    Basic Information

    Device Name
    BD BACTEC Peds Plus/F Culture Vials (plastic)
    K Number
    K151866
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BECTON DICKINSON AND COMPANY
    Date Received
    July 9, 2015
    Decision Date
    February 25, 2016
    Product Code
    MDB
    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
    MDB System, Blood Culturing

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