BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇩🇪 Germany

    INNOVANCE VWF Ac

    K Number: DEN200067 · Decision Sep 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    19
    Review Days
    701

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    Basic Information

    Device Name
    INNOVANCE VWF Ac
    K Number
    DEN200067
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.7293
    Medical Specialty
    Hematology
    Decision
    Unknown
    Applicant
    Siemens Healthcare Diagnostics Products GmbH
    Date Received
    October 28, 2020
    Decision Date
    September 29, 2022
    Product Code
    QTY
    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
    QTY Von Willebrand Factor Assay

    Other Clearances by Siemens Healthcare Diagnostics Products GmbH

    K Number Device Name
    K240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
    K233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
    K220728 vWF Ag
    K212559 CardioPhase® hsCRP
    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
    Search all 19 clearances from Siemens Healthcare Diagnostics Products GmbH →