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

    BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA

    K Number: K852158 · Decision Jun 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    39

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    Basic Information

    Device Name
    BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA
    K Number
    K852158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bioprobe Intl., Inc.
    Date Received
    May 17, 1985
    Decision Date
    June 25, 1985
    Product Code
    LCQ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCQ Fluorescent Immunoassay Gentamicin

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