BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BERICHROM(R) PLASMINOGEN

    K Number: K884766 · Decision Jan 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    145
    Review Days
    51

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    Basic Information

    Device Name
    BERICHROM(R) PLASMINOGEN
    K Number
    K884766
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5715
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    November 14, 1988
    Decision Date
    January 4, 1989
    Product Code
    DDX
    Advisory Committee
    Immunology
    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
    DDX Plasminogen, Antigen, Antiserum, Control

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