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

    ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

    K Number: K102668 · Decision Nov 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    3
    Review Days
    62

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    Basic Information

    Device Name
    ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
    K Number
    K102668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOMERIEUX
    Date Received
    September 16, 2010
    Decision Date
    November 17, 2010
    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 BIOMERIEUX

    K Number Device Name
    K260281 VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
    K141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II