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

    HemosIL Liquid Anti-Xa

    K Number: K213464 · Decision Oct 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    321
    Review Days
    341

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    Basic Information

    Device Name
    HemosIL Liquid Anti-Xa
    K Number
    K213464
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    October 28, 2021
    Decision Date
    October 4, 2022
    Product Code
    KFF
    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
    KFF Assay, Heparin

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    Other Clearances by Instrumentation Laboratory CO

    K Number Device Name
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    K223187 HemosIL Liquid Anti-Xa
    K223090 GEM Premier ChemSTAT
    K223402 HemosIL von Willebrand Factor Antigen
    K213426 HemosIL ReadiPlasTin
    K203790 GEM Premier 5000
    DEN190032 HemosIL Liquid Anti-Xa
    K200033 HemosIL von Willebrand Factor Antigen
    K183549 GEM Premier ChemSTAT
    K183555 GEM Premier ChemSTAT
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