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

    BACTEC MGIT 960 SYSTEM

    K Number: K974883 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    67
    Applicant Total
    632
    Review Days
    122

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    Basic Information

    Device Name
    BACTEC MGIT 960 SYSTEM
    K Number
    K974883
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    December 30, 1997
    Decision Date
    May 1, 1998
    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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