BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY

    K Number: K905643 · Decision Apr 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    116

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    Basic Information

    Device Name
    BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
    K Number
    K905643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Agen Biomedical , Ltd.
    Date Received
    December 17, 1990
    Decision Date
    April 12, 1991
    Product Code
    GHH
    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
    GHH Fibrin Split Products

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