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510(k) Data Aggregation

    K Number
    K022049
    Device Name
    MODIFICATION TO RAICHEM CALCIUM REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-07-19

    (25 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO RAICHEM CALCIUM REAGENT

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

    RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Raichem® Calcium Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot provide the requested information based on the provided text.

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