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

    VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

    K Number: K232967 · Decision Jun 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    29
    Review Days
    265

    Basic Information

    Device Name
    VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
    K Number
    K232967
    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 12, 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.

    K Number Device Name
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    K222378 VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
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    K191766 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
    K190616 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
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