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510(k) Data Aggregation

    K Number
    K981854
    Device Name
    OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    1998-08-18

    (84 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    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 Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Serum Protein Multicalibrator. This document is a regulatory approval letter and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided.

    Therefore, I cannot extract the requested information. The document only states that the FDA has determined the device is "substantially equivalent" to previously marketed devices.

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