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

    HemosIL Silica Clotting Time

    K Number: K253957 · Decision Jan 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    51
    Applicant Total
    5
    Review Days
    30

    Basic Information

    Device Name
    HemosIL Silica Clotting Time
    K Number
    K253957
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory (IL) Co.
    Date Received
    December 10, 2025
    Decision Date
    January 9, 2026
    Product Code
    GFO
    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
    GFO Activated Partial Thromboplastin

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