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

    BACTEC MGIT 960 PZA KIT

    K Number: K021582 · Decision Jul 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    190
    Review Days
    60

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    Basic Information

    Device Name
    BACTEC MGIT 960 PZA KIT
    K Number
    K021582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson & CO
    Date Received
    May 14, 2002
    Decision Date
    July 13, 2002
    Product Code
    MJA
    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
    MJA Susceptibility Test Powders, Antimycobacterial

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