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

    ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

    K Number: K190154 · Decision May 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    16
    Review Days
    91

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
    K Number
    K190154
    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
    January 30, 2019
    Decision Date
    May 1, 2019
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JWY), ordered by most recent decision date.

    ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MTS Gepotidacin 0.016-256 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Biomerieux S.A.

    K Number Device Name
    K250274 ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
    K210757 ETEST Fosfomycin (FO) (0.032-512 µg/mL)
    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)
    K183031 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
    K181092 CHROMID CARBA agar (CARB)
    K180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)
    K162385 RAPIDEC CARBA NP
    K151873 Etest Ceftaroline (0.002 - 32ug/ml)
    Search all 16 clearances from Biomerieux S.A. →