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

    LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD

    K Number: K020968 · Decision Jul 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    10
    Review Days
    111

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    Basic Information

    Device Name
    LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
    K Number
    K020968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pan Probe Biotech, Inc.
    Date Received
    March 26, 2002
    Decision Date
    July 15, 2002
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Pan Probe Biotech, Inc.

    K Number Device Name
    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
    K011011 LIVESURE MORPHINE SCREEN TEST
    K010001 LIVESURE THC SCREEN TEST