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

    Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer

    K Number: K223635 · Decision Jan 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
    K Number
    K223635
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sienco, Inc.
    Date Received
    December 5, 2022
    Decision Date
    January 4, 2023
    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 Sienco, Inc.

    K Number Device Name
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