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

    APOLIPOPROTEIN A-I (APO A-I)

    K Number: K901675 · Decision Apr 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    231
    Review Days
    16

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    Basic Information

    Device Name
    APOLIPOPROTEIN A-I (APO A-I)
    K Number
    K901675
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5590
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    April 10, 1990
    Decision Date
    April 26, 1990
    Product Code
    DEL
    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
    DEL Lipoprotein X, Antigen, Antiserum, Control

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