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510(k) Data Aggregation

    K Number
    K990888

    Validate with FDA (Live)

    Device Name
    MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-04-07

    (28 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K932076
    Predicate For
    K123775
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Liquichek Spinal Fluid Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    Device Description

    Liquichek Spinal Fluid Control is a human based control with added constituents of human origin and pure chemicals. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

    AI/ML Overview

    The provided text is a 510(k) summary for the Liquichek Spinal Fluid Control device. It describes the device, its intended use, and compares it to a substantially equivalent predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) summary focuses on establishing substantial equivalence to a previously cleared device (K932076) based on technological characteristics and intended use. Performance data, acceptance criteria, or a study to demonstrate performance against specific criteria are not included in this type of submission document.

    Therefore, I cannot provide the requested information based on the input text.

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