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

    PREGNOSPIA II

    K Number: K881435 · Decision May 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    130
    Review Days
    52

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    Basic Information

    Device Name
    PREGNOSPIA II
    K Number
    K881435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Organon Teknika Corp.
    Date Received
    April 5, 1988
    Decision Date
    May 27, 1988
    Product Code
    JHJ
    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
    JHJ Agglutination Method, Human Chorionic Gonadotropin

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