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

    ETEST Telavancin (TLA) (0.002-32 ug/mL)

    K Number: K180936 · Decision Jul 3, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    16
    Review Days
    84

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    Basic Information

    Device Name
    ETEST Telavancin (TLA) (0.002-32 ug/mL)
    K Number
    K180936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux S.A.
    Date Received
    April 10, 2018
    Decision Date
    July 3, 2018
    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 S.A.

    K Number Device Name
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    K192738 ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
    K192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
    K191953 ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
    K190154 ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
    K183031 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
    K181092 CHROMID CARBA agar (CARB)
    K162385 RAPIDEC CARBA NP
    K151873 Etest Ceftaroline (0.002 - 32ug/ml)
    Search all 16 clearances from Biomerieux S.A. →