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

    (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT

    K Number: K994194 · Decision Mar 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    13
    Review Days
    106

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    Basic Information

    Device Name
    (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
    K Number
    K994194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Diagnostics, Inc.
    Date Received
    December 13, 1999
    Decision Date
    March 28, 2000
    Product Code
    JBP
    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
    JBP Activated Whole Blood Clotting Time

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    Other Clearances by Cardiovascular Diagnostics, Inc.

    K Number Device Name
    K013305 ENOXAPARIN TEST CARD
    K994159 HMP CONTROLS (TAS) RAPIDPOINT
    K993519 RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
    K990566 TAS ANALYZER, MODEL 1009
    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
    Search all 13 clearances from Cardiovascular Diagnostics, Inc. →