BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

    K Number: K250856 · Decision Jun 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
    K Number
    K250856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomérieux
    Date Received
    March 21, 2025
    Decision Date
    June 12, 2025
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by Biomérieux

    K Number Device Name
    K232395 ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD