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

    VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

    K Number: K232963 · Decision Jun 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    251
    Review Days
    260

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    Basic Information

    Device Name
    VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
    K Number
    K232963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    bioMerieux, Inc.
    Date Received
    September 21, 2023
    Decision Date
    June 7, 2024
    Product Code
    NGZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGZ Susceptibility Test Plate, Antifungal

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    Other Clearances by bioMerieux, Inc.

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    Search all 251 clearances from bioMerieux, Inc. →