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

    EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

    K Number: K970425 · Decision Mar 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
    K Number
    K970425
    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
    February 4, 1997
    Decision Date
    March 6, 1997
    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 Excel Scientific, Inc.

    K Number Device Name
    K971286 EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
    K970467 EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
    K970424 EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
    K963231 EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
    K962146 EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
    K962580 EZ SURE ONESTEP EARLY PREGNANCY TEST
    K955707 ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT