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

    CAPILLARYS URINE

    K Number: K080916 · Decision Jul 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    32
    Review Days
    90

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    Basic Information

    Device Name
    CAPILLARYS URINE
    K Number
    K080916
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5150
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sebia
    Date Received
    April 2, 2008
    Decision Date
    July 1, 2008
    Product Code
    JKM
    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
    JKM Immunochemical, Bence-Jones Protein

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