BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)

    K Number: K930987 · Decision Aug 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    115
    Review Days
    166

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    Basic Information

    Device Name
    CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
    K Number
    K930987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    February 25, 1993
    Decision Date
    August 10, 1993
    Product Code
    KTL
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KTL Anti-Dna Indirect Immunofluorescent Solid Phase

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