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

    ORGEN TEC ANTI-DSDNA ELISA ASSAY

    K Number: K953671 · Decision Nov 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    28
    Applicant Total
    10
    Review Days
    94

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    Basic Information

    Device Name
    ORGEN TEC ANTI-DSDNA ELISA ASSAY
    K Number
    K953671
    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
    August 7, 1995
    Decision Date
    November 9, 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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