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510(k) Data Aggregation

    K Number
    K052148
    Device Name
    TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2005-11-09

    (93 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves whether the Direct TIBC Calibrator Set meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance study details, acceptance criteria, or performance data.

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