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

    HemosIL Factor V Leiden (APC Resistance V)

    K Number: K260551 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    5
    Review Days
    30

    Basic Information

    Device Name
    HemosIL Factor V Leiden (APC Resistance V)
    K Number
    K260551
    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
    February 18, 2026
    Decision Date
    March 20, 2026
    Product Code
    GGW
    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
    GGW Test, Time, Partial Thromboplastin

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    Other Clearances by Instrumentation Laboratory (IL) Co.

    K Number Device Name
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    K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)