BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIAZYME APOLIPOPROTEIN A-1 ASSAY

    K Number: K072977 · Decision Jul 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    6
    Review Days
    268

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    Basic Information

    Device Name
    DIAZYME APOLIPOPROTEIN A-1 ASSAY
    K Number
    K072977
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Atomics
    Date Received
    October 22, 2007
    Decision Date
    July 16, 2008
    Product Code
    MSJ
    Advisory Committee
    Clinical Chemistry
    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
    MSJ Apolipoproteins

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