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

    ENOXAPARIN TEST CARD

    K Number: K013305 · Decision Aug 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    13
    Review Days
    323

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    Basic Information

    Device Name
    ENOXAPARIN TEST CARD
    K Number
    K013305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Diagnostics, Inc.
    Date Received
    October 4, 2001
    Decision Date
    August 23, 2002
    Product Code
    KFF
    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
    KFF Assay, Heparin

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    Other Clearances by Cardiovascular Diagnostics, Inc.

    K Number Device Name
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    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. →