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

    DIRECT IRON REAGENT SET

    K Number: K834396 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    20
    Applicant Total
    20
    Review Days
    69

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    Basic Information

    Device Name
    DIRECT IRON REAGENT SET
    K Number
    K834396
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Seragen Diagnostics, Inc.
    Date Received
    December 14, 1983
    Decision Date
    February 21, 1984
    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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