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

    DIMERTEST

    K Number: K080069 · Decision Feb 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    56
    Applicant Total
    10
    Review Days
    34

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DIMERTEST
    K Number
    K080069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Diagnostica, Inc.
    Date Received
    January 10, 2008
    Decision Date
    February 13, 2008
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DAP), ordered by most recent decision date.

    HemosIL D-Dimer HS 500

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA® - Liatest® D-Di

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL D-Dimer HS

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL D-Dimer HS

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA LIATEST D-DI

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIDAS D-DIMER EXCLUSION II (DEX2)

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by American Diagnostica, Inc.

    K Number Device Name
    K063323 SPECTROLYSE PAI-1, MODEL 101201
    K052124 ACTICLOT, MODEL 824
    K013637 ACTICHROME HEPARIN (ANTI-FIIA)
    K013492 IMUBIND TPA ELISA, MODEL 860
    K013318 ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
    K013168 IMUBIND PLASMA PAI-1 ELISA,MODEL 822
    K012386 ACTICLOT PROTEIN S, MODEL 843L
    K940490 DV TEST AND DVV CONFIRM
    K935254 DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA