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510(k) Data Aggregation

    K Number
    K973761
    Device Name
    MICRO-STRIP FOR OPIATE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1997-12-24

    (83 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICRO-STRIP FOR OPIATE METABOLITES

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

    The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "Micro-Strip for Opiate Metabolites" device. It does not contain information about acceptance criteria, device performance studies, or the specifics of such studies. Therefore, I cannot generate the requested table and answer the questions based on the given text.

    The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It outlines regulatory classifications, contact information for further inquiries, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

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