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

    THROMBELASTOGRAPH

    K Number: K904204 · Decision Nov 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    48
    Applicant Total
    7
    Review Days
    50

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    Basic Information

    Device Name
    THROMBELASTOGRAPH
    K Number
    K904204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Haemoscope Corp.
    Date Received
    September 12, 1990
    Decision Date
    November 1, 1990
    Product Code
    GKP
    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
    GKP Instrument, Coagulation, Automated

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    Other Clearances by Haemoscope Corp.

    K Number Device Name
    K062604 RAPIDTEG TEG-ACT TEST
    K041502 THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
    K002177 THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
    K993678 THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
    K954437 THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
    K895844 THROMBELASTOGRAPH(R)