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

    QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK

    K Number: K875281 · Decision Feb 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    29
    Applicant Total
    58
    Review Days
    48

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    Basic Information

    Device Name
    QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
    K Number
    K875281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Diag, A Div. of Erbamont, Inc.
    Date Received
    December 24, 1987
    Decision Date
    February 10, 1988
    Product Code
    DEM
    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
    DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

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