BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

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

    K Number: K240315 · Decision Oct 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    19
    Review Days
    251

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    Basic Information

    Device Name
    INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
    K Number
    K240315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7295
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics Products GmbH
    Date Received
    February 2, 2024
    Decision Date
    October 10, 2024
    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

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    DEN200067 INNOVANCE VWF Ac
    K212379 N Latex FLC kappa, N Latex FLC lambda
    K201496 N Latex FLC kappa, N Latex FLC lambda
    K193047 N Latex FLC kappa, N Latex FLC lambda
    K190879 N Latex FLC kappa, N Latex FLC lambda
    K182098 N Latex FLC kappa assay, N Latex FLC lambda assay
    K181525 INNOVANCE Free PS Ag
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