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

    ORTHO CLASSICAL PATHWAY COMPL. TEST

    K Number: K821898 · Decision Jul 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    12
    Applicant Total
    126
    Review Days
    18

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    Basic Information

    Device Name
    ORTHO CLASSICAL PATHWAY COMPL. TEST
    K Number
    K821898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5250
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    June 28, 1982
    Decision Date
    July 16, 1982
    Product Code
    DBA
    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
    DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

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