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510(k) Data Aggregation

    K Number
    K110534
    Device Name
    RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
    Manufacturer
    RANDOX LABORATORIES LIMITED
    Date Cleared
    2012-01-23

    (332 days)

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

    The Randox Liquid Cardiac Controls Level 1, Level 2 and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I and Troponin T rionsoftware no clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only

    Device Description

    The Randox Liquid Cardiac Controls Level 1, Level 2 and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I and Troponin T.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming the device's substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information from the provided text.

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