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

    HemosIL Liquid Anti-Xa

    K Number: DEN190032 · Decision Sep 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    321
    Review Days
    450

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    Basic Information

    Device Name
    HemosIL Liquid Anti-Xa
    K Number
    DEN190032
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.7295
    Medical Specialty
    Hematology
    Decision
    Unknown
    Applicant
    Instrumentation Laboratory CO
    Date Received
    June 25, 2019
    Decision Date
    September 17, 2020
    Product Code
    QLU
    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
    QLU Anti-Factor Xa Activity Test System, Apixaban

    Similar 510(k) Clearances

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

    INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL Liquid Anti-Xa

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

    Other Clearances by Instrumentation Laboratory CO

    K Number Device Name
    K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
    K223187 HemosIL Liquid Anti-Xa
    K223090 GEM Premier ChemSTAT
    K223402 HemosIL von Willebrand Factor Antigen
    K213464 HemosIL Liquid Anti-Xa
    K213426 HemosIL ReadiPlasTin
    K203790 GEM Premier 5000
    K200033 HemosIL von Willebrand Factor Antigen
    K183549 GEM Premier ChemSTAT
    K183555 GEM Premier ChemSTAT
    Search all 321 clearances from Instrumentation Laboratory CO →