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

    DIAZYME LP(A) ASSAY

    K Number: K082488 · Decision Jan 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    42
    Applicant Total
    6
    Review Days
    138

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    Basic Information

    Device Name
    DIAZYME LP(A) ASSAY
    K Number
    K082488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Atomics
    Date Received
    August 28, 2008
    Decision Date
    January 13, 2009
    Product Code
    DFC
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

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