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

    ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY

    K Number: K952055 · Decision Jul 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    28
    Applicant Total
    27
    Review Days
    77

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    Basic Information

    Device Name
    ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
    K Number
    K952055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    May 2, 1995
    Decision Date
    July 18, 1995
    Product Code
    LRM
    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
    LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

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