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

    HEALTHCHECK HOME PREGNANCY TEST KIT

    K Number: K841595 · Decision May 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    5
    Review Days
    43

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    Basic Information

    Device Name
    HEALTHCHECK HOME PREGNANCY TEST KIT
    K Number
    K841595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Timex Medical Products Corp.
    Date Received
    April 18, 1984
    Decision Date
    May 31, 1984
    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 Timex Medical Products Corp.

    K Number Device Name
    K841616 TIMEX HEALTHCHECK DIGITAL BP MONITOR
    K840228 HEALTHCHECK AUTO INFLATE DIGITAL BP
    K821437 DIGITAL BLOOD PRESSURE METER
    K821436 ELECTRONIC DIGITAL THERMOMETER