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

    BACTEC CULTURE VIALS, LYTIC, ANAEROBIC

    K Number: K954930 · Decision Feb 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    67
    Applicant Total
    13
    Review Days
    113

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    Basic Information

    Device Name
    BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
    K Number
    K954930
    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 Diagnostic Instrument Systems
    Date Received
    October 26, 1995
    Decision Date
    February 16, 1996
    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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    Other Clearances by Becton Dickinson Diagnostic Instrument Systems

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    K960827 QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
    K954921 BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
    K954925 BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
    K954927 BACTEC PEDS PLUS/F CULTURE VIALS
    K954924 BACTEC PEDS PLUS CLUTURE VIALS
    K955504 QBC ACCUREAD SYSTEM
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