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

    IGM RHEUMATOID FACTOR TEST KIT

    K Number: K851099 · Decision Apr 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    5
    Review Days
    37

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    Basic Information

    Device Name
    IGM RHEUMATOID FACTOR TEST KIT
    K Number
    K851099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Breit Laboratories, Inc.
    Date Received
    March 19, 1985
    Decision Date
    April 25, 1985
    Product Code
    DHR
    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
    DHR System, Test, Rheumatoid Factor

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