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

    TAS ANALYZER, MODEL 1009

    K Number: K990566 · Decision May 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    13
    Review Days
    81

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    Basic Information

    Device Name
    TAS ANALYZER, MODEL 1009
    K Number
    K990566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Diagnostics, Inc.
    Date Received
    February 22, 1999
    Decision Date
    May 14, 1999
    Product Code
    JPA
    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
    JPA System, Multipurpose For In Vitro Coagulation Studies

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    K981206 TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
    K981178 THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
    K971748 TAS PT-NCTEST CONTROLS
    K961814 THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
    K961189 TAS A PTT TEST CONTROLS
    K960234 TAS HMT CONTROLS
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