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

    SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER

    K Number: K952560 · Decision Sep 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    5
    Review Days
    95

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    Basic Information

    Device Name
    SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
    K Number
    K952560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sienco, Inc.
    Date Received
    June 2, 1995
    Decision Date
    September 5, 1995
    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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    Other Clearances by Sienco, Inc.

    K Number Device Name
    K223635 Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
    K032952 AIACT KIT
    K002528 SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
    K984141 GBACT + KIT