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

    TFR

    K Number: K981208 · Decision Oct 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    202

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    Basic Information

    Device Name
    TFR
    K Number
    K981208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ramco Laboratories, Inc.
    Date Received
    April 2, 1998
    Decision Date
    October 21, 1998
    Product Code
    JNM
    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
    JNM Immunochemical, Transferrin

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