BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

    K Number: K170670 · Decision May 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    251
    Review Days
    86

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    Basic Information

    Device Name
    Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
    K Number
    K170670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    bioMerieux, Inc.
    Date Received
    March 6, 2017
    Decision Date
    May 31, 2017
    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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