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510(k) Data Aggregation

    K Number
    K961941
    Device Name
    LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
    Manufacturer
    BIO-RAD
    Date Cleared
    1996-09-16

    (119 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K954322
    Why did this record match?
    Reference Devices :

    K954322

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

    Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of a laboratory testing procedures for the analytes listed in this package insert.

    Device Description

    Liquichek Immunoassay Plus Control is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.

    AI/ML Overview

    This document is a 510(k) Summary for a quality control device called "Liquichek Immunoassay Plus Control." It does not describe an AI/ML powered medical device, an imaging device, or a device that would typically have acceptance criteria in the manner requested.

    Therefore, I cannot provide a response filling out the requested information (acceptance criteria, study details, expert involvement, sample sizes, ground truth, etc.). This document is for a laboratory control product and focuses on its intended use, form, matrix, and storage, and compares it to a substantially equivalent device.

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