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510(k) Data Aggregation

    K Number
    K013332
    Device Name
    LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2001-11-20

    (42 days)

    Product Code
    JJY
    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

    LiniCAL™ Protein I Calibration Verifiers Levels A – E for Beckman Coulter Immage™ is intended for use as an assayed quality control material for analysis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a device called "LiniCAL™ Protein I Calibration Verifiers Levels A-E for Beckman Coulter Immage™". It states that the device has been found substantially equivalent to a legally marketed predicate device.

    The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. Such information would typically be found within the 510(k) submission itself, which is not provided here. The letter primarily confirms the FDA's decision regarding substantial equivalence for marketing purposes.

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

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