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

    ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD

    K Number: K870672 · Decision Apr 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    374
    Applicant Total
    253
    Review Days
    41

    Basic Information

    Device Name
    ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
    K Number
    K870672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. DUPONT DE NEMOURS & CO., INC.
    Date Received
    February 19, 1987
    Decision Date
    April 1, 1987
    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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