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

    EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

    K Number: K963231 · Decision Dec 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    8
    Review Days
    107

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    Basic Information

    Device Name
    EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
    K Number
    K963231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excel Scientific, Inc.
    Date Received
    August 19, 1996
    Decision Date
    December 4, 1996
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    K970424 EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
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    K962580 EZ SURE ONESTEP EARLY PREGNANCY TEST
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