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

    THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

    K Number: K041502 · Decision Sep 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    86

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    Basic Information

    Device Name
    THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
    K Number
    K041502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haemoscope Corp.
    Date Received
    June 7, 2004
    Decision Date
    September 1, 2004
    Product Code
    JOZ
    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
    JOZ System, Automated Platelet Aggregation

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    Other Clearances by Haemoscope Corp.

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