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

    APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1

    K Number: K851649 · Decision Jun 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    12
    Review Days
    44

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    Basic Information

    Device Name
    APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
    K Number
    K851649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Photec Diagnostics, Inc.
    Date Received
    April 22, 1985
    Decision Date
    June 5, 1985
    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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