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    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇷 Greece

    FERRITIN-LATEX, MODELS 1418-2070, 1418-0279

    K Number: K062746 · Decision Nov 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    3
    Review Days
    67

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    Basic Information

    Device Name
    FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
    K Number
    K062746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicon Hellas S.A
    Date Received
    September 14, 2006
    Decision Date
    November 20, 2006
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DBF Ferritin, Antigen, Antiserum, Control

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    Other Clearances by Medicon Hellas S.A

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