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

    INSURE PREGNANCY TEST

    K Number: K991515 · Decision May 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    INSURE PREGNANCY TEST
    K Number
    K991515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inbios Intl., Inc.
    Date Received
    April 30, 1999
    Decision Date
    May 28, 1999
    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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