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

    IMMPULSE TOBRAMYCIN ASSAY REAGENTS

    K Number: K840847 · Decision Apr 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    IMMPULSE TOBRAMYCIN ASSAY REAGENTS
    K Number
    K840847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    February 24, 1984
    Decision Date
    April 4, 1984
    Product Code
    LCR
    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
    LCR Fluorescent Immunoassay, Tobramycin

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