BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

    K Number: K191638 · Decision Mar 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
    K Number
    K191638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtest DX
    Date Received
    June 19, 2019
    Decision Date
    March 12, 2020
    Product Code
    DIO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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