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

    BACTEC MGIT 960 SIR KITS

    K Number: K003062 · Decision Jun 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    632
    Review Days
    247

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    Basic Information

    Device Name
    BACTEC MGIT 960 SIR KITS
    K Number
    K003062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    October 2, 2000
    Decision Date
    June 6, 2001
    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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