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510(k) Data Aggregation

    K Number
    K990391
    Device Name
    ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-03-15

    (34 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Abbott Lyophilized Assayed Chemistry Control 3 is intended for use as a guality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Abbott Lyophilized Assayed Chemistry Control 3. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

    The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory responsibilities and contacts for further information.

    Therefore, I cannot provide the requested table and study details based on the provided text. The document is administrative in nature, confirming regulatory clearance rather than presenting technical performance data.

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