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510(k) Data Aggregation

    K Number
    K983159
    Device Name
    DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1998-11-05

    (57 days)

    Product Code
    DKB
    Regulation Number
    862.3200
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS

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

    The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI's drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing authorization letter from the FDA, it does not contain information about the acceptance criteria and study details. It permits the marketing of "Drugs of Abuse Urine Calibrators and Controls" and states its intended use, but does not provide any performance data, study design, or ground truth establishment methods. Therefore, I cannot extract the requested information from this document.

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