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

    BIOCLONE'S ELEGANCE HCG ELISA KIT

    K Number: K910420 · Decision Feb 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    BIOCLONE'S ELEGANCE HCG ELISA KIT
    K Number
    K910420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bioclone Australia Pty , Ltd.
    Date Received
    January 30, 1991
    Decision Date
    February 26, 1991
    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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