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

    MINISTICK PREGNANCY TEST

    K Number: K960733 · Decision May 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    10
    Review Days
    69

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    Basic Information

    Device Name
    MINISTICK PREGNANCY TEST
    K Number
    K960733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Biomedical Corp.
    Date Received
    February 22, 1996
    Decision Date
    May 1, 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 Vanguard Biomedical Corp.

    K Number Device Name
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    K914254 HOMECLINIC ONE STEP PREGNANCY TEST
    K914253 PROCLINIC ONE STEP PREGNANCY TEST
    K910351 MINICLINIC OVULATION PREDICTION TEST
    K895560 MODIFIED HOMECLINIC PREGNANCY TEST
    K894012 MINICLINIC PREGNANCY TEST
    K891762 MINICLINIC OVULATION PREDICTION TEST
    K883826 HOME CLINIC PREGNANCY TEST