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

    SELFCARE EARLY PREGNANCY TEST

    K Number: K960436 · Decision Mar 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    223
    Applicant Total
    15
    Review Days
    48

    Basic Information

    Device Name
    SELFCARE EARLY PREGNANCY TEST
    K Number
    K960436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SELFCARE, INC.
    Date Received
    January 31, 1996
    Decision Date
    March 19, 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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