BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DART IRON & IRON BINDING CAPACITY REAGENT

    K Number: K854305 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    20
    Applicant Total
    101
    Review Days
    18

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    Basic Information

    Device Name
    DART IRON & IRON BINDING CAPACITY REAGENT
    K Number
    K854305
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    October 25, 1985
    Decision Date
    November 12, 1985
    Product Code
    CFM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CFM Bathophenanthroline, Colorimetry, Iron (Non-Heme)

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