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

    LIVESURE COCAINE SCREEN TEST

    K Number: K010967 · Decision Apr 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    10
    Review Days
    15

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    Basic Information

    Device Name
    LIVESURE COCAINE SCREEN TEST
    K Number
    K010967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pan Probe Biotech, Inc.
    Date Received
    April 2, 2001
    Decision Date
    April 17, 2001
    Product Code
    DIO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    Y

    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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    Other Clearances by Pan Probe Biotech, Inc.

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    K012133 LIVESURE BARBITURATES SCREEN TEST
    K011610 LIVESURE METHAMPHETAMINE SCREEN TESTS
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