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

    ALERT A,HDL-APOLIPOROTEIN A, TEST KIT

    K Number: K802610 · Decision Jan 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    44
    Review Days
    76

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    Basic Information

    Device Name
    ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K Number
    K802610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    October 21, 1980
    Decision Date
    January 5, 1981
    Product Code
    DER
    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
    DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control

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