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

    AGEN DIMERTEST GOLD EIA

    K Number: K945642 · Decision Oct 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    343

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    Basic Information

    Device Name
    AGEN DIMERTEST GOLD EIA
    K Number
    K945642
    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
    November 16, 1994
    Decision Date
    October 25, 1995
    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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    Other Clearances by Agen Biomedical , Ltd.

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    K890189 AGEN DIMERTEST EIA
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