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510(k) Data Aggregation

    K Number
    K023853
    Device Name
    K-ASSAY LP(A) CONTROLS
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-12-13

    (24 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY LP(A) CONTROLS

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

    The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.

    Device Description

    Not Found

    AI/ML Overview

    While the provided text describes the FDA's decision regarding the K-ASSAY® Lp(a) Controls device, it does not contain any information about acceptance criteria, study details, or performance data. The document is a 510(k) clearance letter (K023853), which states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the requested information. The text focuses on regulatory approval rather than the technical details of the device's performance study.

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