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

    XACT NEISSERIA

    K Number: K880511 · Decision Aug 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    45
    Review Days
    198

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    Basic Information

    Device Name
    XACT NEISSERIA
    K Number
    K880511
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Austin Biological Laboratories
    Date Received
    February 9, 1988
    Decision Date
    August 25, 1988
    Product Code
    JSX
    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
    JSX Kit, Identification, Neisseria Gonorrhoeae

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