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

    QUICK & SURE ONESTEP HOME PREGNANCY TEST

    K Number: K981892 · Decision Aug 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    1
    Review Days
    81

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    Basic Information

    Device Name
    QUICK & SURE ONESTEP HOME PREGNANCY TEST
    K Number
    K981892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Abacus Diagnostics
    Date Received
    May 29, 1998
    Decision Date
    August 18, 1998
    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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