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

    RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.

    K Number: K802448 · Decision Jan 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    34
    Review Days
    89

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    Basic Information

    Device Name
    RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
    K Number
    K802448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Syn-Kit, Inc.
    Date Received
    October 8, 1980
    Decision Date
    January 5, 1981
    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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    K843758 UROPAPER EIKEN GK
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