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

    STRATUS AMIKACIN FLUOROMETRIC

    K Number: K832336 · Decision Aug 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    19
    Applicant Total
    149
    Review Days
    44

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    Basic Information

    Device Name
    STRATUS AMIKACIN FLUOROMETRIC
    K Number
    K832336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    July 18, 1983
    Decision Date
    August 31, 1983
    Product Code
    KLQ
    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
    KLQ Radioimmunoassay, Amikacin

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