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

    VISI-NEISSERIA

    K Number: K913456 · Decision Oct 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    VISI-NEISSERIA
    K Number
    K913456
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kev Connecticut Diagnostics, Inc.
    Date Received
    August 5, 1991
    Decision Date
    October 11, 1991
    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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    Other Clearances by Kev Connecticut Diagnostics, Inc.

    K Number Device Name
    K910537 VISI-STREP