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

    STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM

    K Number: K832408 · Decision Aug 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    149
    Review Days
    36

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    Basic Information

    Device Name
    STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
    K Number
    K832408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    July 21, 1983
    Decision Date
    August 26, 1983
    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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