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

    AUTODIMER ASSAY MODEL # 1431

    K Number: K012755 · Decision Mar 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    211

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    Basic Information

    Device Name
    AUTODIMER ASSAY MODEL # 1431
    K Number
    K012755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xtrana, Inc.
    Date Received
    August 16, 2001
    Decision Date
    March 15, 2002
    Product Code
    DAP
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

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