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

    AGEN DIMERTEST EIA

    K Number: K890189 · Decision Mar 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    45

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    Basic Information

    Device Name
    AGEN DIMERTEST EIA
    K Number
    K890189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Agen Biomedical , Ltd.
    Date Received
    January 17, 1989
    Decision Date
    March 3, 1989
    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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    Other Clearances by Agen Biomedical , Ltd.

    K Number Device Name
    K993276 SIMPLIFY D-DIMER, MODEL DCGK1
    K974596 DIMERTEST LATEX ASSAY
    K945642 AGEN DIMERTEST GOLD EIA
    K905643 BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
    K882944 DIMERTEST(R) LATEX