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

    LIVESURE MORPHINE SCREEN TEST

    K Number: K011011 · Decision Apr 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    10
    Review Days
    9

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    Basic Information

    Device Name
    LIVESURE MORPHINE SCREEN TEST
    K Number
    K011011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3640
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pan Probe Biotech, Inc.
    Date Received
    April 4, 2001
    Decision Date
    April 13, 2001
    Product Code
    DOE
    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
    DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

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    Other Clearances by Pan Probe Biotech, Inc.

    K Number Device Name
    K020968 LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
    K013796 LIVESURE METHADONE SCREEN TESTS
    K012131 LIVESURE BENZODIAZEPINES SCREEN TESTS
    K012107 LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
    K012133 LIVESURE BARBITURATES SCREEN TEST
    K011610 LIVESURE METHAMPHETAMINE SCREEN TESTS
    K011609 LIVESURE AMPHETAMINE SCREEN TEST
    K010967 LIVESURE COCAINE SCREEN TEST
    K010001 LIVESURE THC SCREEN TEST