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

    VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

    K Number: K251579 · Decision Aug 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    288
    Applicant Total
    251
    Review Days
    90

    Basic Information

    Device Name
    VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
    K Number
    K251579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    bioMerieux, Inc.
    Date Received
    May 23, 2025
    Decision Date
    August 21, 2025
    Product Code
    LON
    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
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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