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510(k) Data Aggregation

    K Number
    K012250
    Device Name
    RAICHEM MULTI-ANALYTE CALIBRATOR
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2001-09-24

    (69 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Mult-Analyte Serum Calibrator is used for the calibration of clinical chemistry assays. The material is well suited for automated analyzers.

    Device Description

    Not Found

    AI/ML Overview

    This is a notification from the FDA regarding the 510(k) premarket notification for the RAICHEM® Multi-Analyte Calibrator. The document states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

    The document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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