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

    ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

    K Number: K031857 · Decision Sep 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    29
    Applicant Total
    32
    Review Days
    80

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    Basic Information

    Device Name
    ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
    K Number
    K031857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Diagnostics Corp.
    Date Received
    June 16, 2003
    Decision Date
    September 4, 2003
    Product Code
    DEM
    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
    DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

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