BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

    K Number: K153569 · Decision Jun 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    1
    Review Days
    190

    Basic Information

    Device Name
    Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
    K Number
    K153569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    LIOFILCHEM S.R.L
    Date Received
    December 15, 2015
    Decision Date
    June 22, 2016
    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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