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

    QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL

    K Number: K872078 · Decision Jun 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
    K Number
    K872078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Solomon Park Research Laboratories
    Date Received
    May 29, 1987
    Decision Date
    June 18, 1987
    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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