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

    TINAQUANT RHEUMATOID FACTOR ASSAY

    K Number: K971379 · Decision Jun 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    340
    Review Days
    64

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    Basic Information

    Device Name
    TINAQUANT RHEUMATOID FACTOR ASSAY
    K Number
    K971379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    April 14, 1997
    Decision Date
    June 17, 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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