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

    ALBUMIN BCP

    K Number: K844426 · Decision Jan 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    340
    Review Days
    53

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    Basic Information

    Device Name
    ALBUMIN BCP
    K Number
    K844426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    November 15, 1984
    Decision Date
    January 7, 1985
    Product Code
    CJW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CJW Bromcresol Purple Dye-Binding, Albumin

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