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

    SIMPLIFY D-DIMER, MODEL DCGK1

    K Number: K993276 · Decision Dec 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    75

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    Basic Information

    Device Name
    SIMPLIFY D-DIMER, MODEL DCGK1
    K Number
    K993276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Agen Biomedical , Ltd.
    Date Received
    September 30, 1999
    Decision Date
    December 14, 1999
    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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