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510(k) Data Aggregation

    K Number
    K974596
    Device Name
    DIMERTEST LATEX ASSAY
    Manufacturer
    AGEN BIOMEDICAL LTD.
    Date Cleared
    1998-05-26

    (168 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIMERTEST LATEX ASSAY

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

    The Dimertest Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) clearance for the Dimertest Latex Assay but does not contain any information regarding specific acceptance criteria, study details, or performance metrics.

    Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the regulatory clearance of the device as substantially equivalent to a predicate device.

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