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510(k) Data Aggregation

    K Number
    K090283
    Device Name
    CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2009-06-05

    (120 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

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

    SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (SYNCHRON CX Multi-Analyte Mixture Calibrators 1, 2, and 3) that is substantially equivalent to a legally marketed predicate device. The document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a regulatory approval letter from the FDA.

    Therefore, I cannot provide the requested information based on the given document.

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