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

    ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

    K Number: K011337 · Decision Oct 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    167

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    Basic Information

    Device Name
    ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
    K Number
    K011337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accumetrics, Inc.
    Date Received
    May 2, 2001
    Decision Date
    October 16, 2001
    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 Accumetrics, Inc.

    K Number Device Name
    K141427 ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
    K051231 VERIFYNOW-P2Y12 ASSAY
    K042423 VERIFYNOW-ASPIRIN ASSAY
    K012701 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
    K013596 MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
    K992531 ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM