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

    INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST

    K Number: K994398 · Decision Jul 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    43
    Review Days
    212

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    Basic Information

    Device Name
    INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
    K Number
    K994398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Scientific Designs, Inc.
    Date Received
    December 28, 1999
    Decision Date
    July 27, 2000
    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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