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

    HemosIL CL HIT-IgG(PF4-H)

    K Number: K243374 · Decision Jan 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HemosIL CL HIT-IgG(PF4-H)
    K Number
    K243374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7695
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory (IL) Co.
    Date Received
    October 30, 2024
    Decision Date
    January 28, 2025
    Product Code
    LCO
    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
    LCO Platelet Factor 4 Radioimmunoassay

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LCO), ordered by most recent decision date.

    PF4 Enhanced assay

    FDA 510(k)
    FDA Class 2 ·Hematology

    PF4 IgG assay

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

    FDA 510(k)
    FDA Class 2 ·Hematology

    PF4 IGG

    FDA 510(k)
    FDA Class 2 ·Hematology

    ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Instrumentation Laboratory (IL) Co.

    K Number Device Name
    K260551 HemosIL Factor V Leiden (APC Resistance V)
    K253957 HemosIL Silica Clotting Time
    K251968 HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
    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)