BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    TRACE TRANSFERRIN REAGENT

    K Number: K932713 · Decision Sep 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    55
    Review Days
    118

    Basic Information

    Device Name
    TRACE TRANSFERRIN REAGENT
    K Number
    K932713
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TRACE SCIENTIFIC LTD.
    Date Received
    June 4, 1993
    Decision Date
    September 30, 1993
    Product Code
    DDQ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DDQ Antigen, Antiserum, Control, Antithrombin Iii

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