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

    RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

    K Number: K011068 · Decision Apr 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    15
    Review Days
    367

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    Basic Information

    Device Name
    RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
    K Number
    K011068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rhigene, Inc.
    Date Received
    April 9, 2001
    Decision Date
    April 11, 2002
    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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