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510(k) Data Aggregation

    K Number
    K982035
    Device Name
    OLYMPUS CALCIUM ARSENAZO III REAGENT
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    1998-06-24

    (14 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    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 Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.

    Device Description

    Olympus Calcium Arsenazo Reagent

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Olympus Calcium Arsenazo Reagent. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested. The document primarily discusses the substantial equivalence of the device to pre-amendment devices and regulatory information.

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

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