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

    ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY

    K Number: K954831 · Decision May 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    201

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    Basic Information

    Device Name
    ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
    K Number
    K954831
    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
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by Orgentec

    K Number Device Name
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    K954814 ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
    K954815 ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
    K954829 ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
    K960274 ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
    K955134 ORGENTEC ENASCREEN ELISA ASSAY
    K955133 ORGENTEC ENASCREEN PIN IMMUNO ASSAY
    K953671 ORGEN TEC ANTI-DSDNA ELISA ASSAY