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

    BIOTROL ALBUMIN

    K Number: K885094 · Decision Feb 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    46
    Review Days
    63

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    Basic Information

    Device Name
    BIOTROL ALBUMIN
    K Number
    K885094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biotrol, USA, Inc.
    Date Received
    December 9, 1988
    Decision Date
    February 10, 1989
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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