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

    IMMPULSE THEOPHYLLINE ASSAY REAGENTS

    K Number: K840758 · Decision Apr 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    7
    Review Days
    41

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    Basic Information

    Device Name
    IMMPULSE THEOPHYLLINE ASSAY REAGENTS
    K Number
    K840758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    February 23, 1984
    Decision Date
    April 4, 1984
    Product Code
    LER
    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
    LER Fluorescent Immunoassay, Theophylline

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    K840847 IMMPULSE TOBRAMYCIN ASSAY REAGENTS
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