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

    IMMPULSE AMIKACIN ASSAY REAGENTS

    K Number: K841161 · Decision May 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    19
    Applicant Total
    7
    Review Days
    44

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    Basic Information

    Device Name
    IMMPULSE AMIKACIN ASSAY REAGENTS
    K Number
    K841161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    March 19, 1984
    Decision Date
    May 2, 1984
    Product Code
    KLQ
    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
    KLQ Radioimmunoassay, Amikacin

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