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

    ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY

    K Number: K954830 · Decision May 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    27
    Applicant Total
    10
    Review Days
    201

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    Basic Information

    Device Name
    ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
    K Number
    K954830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orgentec
    Date Received
    October 20, 1995
    Decision Date
    May 8, 1996
    Product Code
    LKP
    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
    LKP Anti-Sm Antibody, Antigen And Control

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