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

    GONOPOX TEST KIT

    K Number: K960759 · Decision Sep 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    205

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    Basic Information

    Device Name
    GONOPOX TEST KIT
    K Number
    K960759
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtex Laboratories, Inc.
    Date Received
    February 26, 1996
    Decision Date
    September 18, 1996
    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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