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

    QMS TOBRAMYCIN

    K Number: K060998 · Decision Jul 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    28
    Review Days
    101

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    Basic Information

    Device Name
    QMS TOBRAMYCIN
    K Number
    K060998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    April 11, 2006
    Decision Date
    July 21, 2006
    Product Code
    LCR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCR Fluorescent Immunoassay, Tobramycin

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