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

    QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)

    K Number: K973464 · Decision Oct 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    321
    Review Days
    40

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    Basic Information

    Device Name
    QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
    K Number
    K973464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    September 12, 1997
    Decision Date
    October 22, 1997
    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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