BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    SELFCARE EARLY PREGNANCY TEST

    K Number: K955903 · Decision Mar 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    4
    Review Days
    68

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    Basic Information

    Device Name
    SELFCARE EARLY PREGNANCY TEST
    K Number
    K955903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cambridge Diagnostics Ireland, Ltd.
    Date Received
    December 29, 1995
    Decision Date
    March 6, 1996
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Cambridge Diagnostics Ireland, Ltd.

    K Number Device Name
    K013907 INVERNESS MEDICAL EARLY PREGNANCY TEST
    K970768 HUMAN LYME IGM WESTERN BLOT KIT
    K970761 LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)