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510(k) Data Aggregation

    K Number
    K981609
    Device Name
    BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-06-03

    (29 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of in Bilirubin (Direct) in serum. For IN VITRO diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Bilirubin-SL (Direct) Assay." It does not contain information about acceptance criteria, device performance, specific study details, or ground truth establishment. The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not detail the technical performance data that led to this decision.

    Therefore, I cannot provide the requested information based on the provided text. The document is regulatory approval, not a performance study report.

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