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510(k) Data Aggregation

    K Number
    K990162
    Device Name
    ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-01-28

    (9 days)

    Product Code
    JJX
    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 Liquid Ammonia Control is intended for use as a quality 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 Liquid Ammonia Control. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a device.

    Therefore, I cannot provide a response to your request based on the provided text. The letter is a regulatory approval document, not a scientific study report.

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