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

    BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM

    K Number: K962423 · Decision Aug 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    33
    Review Days
    39

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    Basic Information

    Device Name
    BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM
    K Number
    K962423
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Microbiology Systems
    Date Received
    June 24, 1996
    Decision Date
    August 2, 1996
    Product Code
    JST
    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
    JST Kit, Fastidious Organisms

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