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

    ABBOTT QLUICKSTART IRON TEST, ITEM #5A29

    K Number: K913705 · Decision Oct 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    20
    Applicant Total
    288
    Review Days
    51

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    Basic Information

    Device Name
    ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
    K Number
    K913705
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    August 19, 1991
    Decision Date
    October 9, 1991
    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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