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

    MIDSTREAM HOME REGNANCY TEST

    K Number: K973825 · Decision Dec 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    8
    Review Days
    73

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    Basic Information

    Device Name
    MIDSTREAM HOME REGNANCY TEST
    K Number
    K973825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Germaine Laboratories, Inc.
    Date Received
    October 7, 1997
    Decision Date
    December 19, 1997
    Product Code
    DHA
    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
    DHA System, Test, Human Chorionic Gonadotropin

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    Other Clearances by Germaine Laboratories, Inc.

    K Number Device Name
    K051727 AIMSTICK URINE REAGENT STRIPS
    K013857 AIMSTEP PREGNANCY
    K991369 ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
    K981165 AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
    K980531 AIMSTEP PREGNANCY
    K974368 AIMSTICK PBD PREGNANCY
    K974512 AIMSTICK PBD COMBO PREGNANCY