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

    DRYSIDE NEISSERIA

    K Number: K954784 · Decision Jan 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    121
    Review Days
    105

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    Basic Information

    Device Name
    DRYSIDE NEISSERIA
    K Number
    K954784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Difco Laboratories, Inc.
    Date Received
    October 17, 1995
    Decision Date
    January 30, 1996
    Product Code
    LTS
    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
    LTS Test Reagents, Neisseria Gonorrhoeae Biochemical

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