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

    REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

    K Number: K034013 · Decision Jan 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    23
    Review Days
    15

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    Basic Information

    Device Name
    REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
    K Number
    K034013
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Corgenix, Inc.
    Date Received
    December 24, 2003
    Decision Date
    January 8, 2004
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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