BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

    K Number: K063086 · Decision Aug 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    9
    Review Days
    302

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    Basic Information

    Device Name
    TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
    K Number
    K063086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermo Electron OY
    Date Received
    October 10, 2006
    Decision Date
    August 8, 2007
    Product Code
    DDG
    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
    DDG Transferrin, Antigen, Antiserum, Control

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