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510(k) Data Aggregation

    K Number
    K981914
    Device Name
    TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-11-26

    (543 days)

    Product Code
    JJX,CFQ
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assayed human serum pool is designed for use as a high control fluid to be used in conjunction with the Binding Site MININEPH® range of pro

    Device Description

    Not Found

    AI/ML Overview

    The document provided is a 510(k) clearance letter from the FDA for two control serum reference preparations. It does not contain information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any details about AI algorithms, ground truth, or statistical analyses typically associated with such studies.

    Therefore, I cannot provide the requested information based on the given text. The document is strictly a regulatory approval notice for a medical device.

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