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

    IMMPULSE GENTAMICIN ASSAY REAGENTS

    K Number: K841162 · Decision May 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    44

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    Basic Information

    Device Name
    IMMPULSE GENTAMICIN ASSAY REAGENTS
    K Number
    K841162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    March 19, 1984
    Decision Date
    May 2, 1984
    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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    Other Clearances by Paragon Diagnostics, Inc.

    K Number Device Name
    K841161 IMMPULSE AMIKACIN ASSAY REAGENTS
    K840852 IMMPULSE T4 ASSAY REAGENTS
    K840758 IMMPULSE THEOPHYLLINE ASSAY REAGENTS
    K840847 IMMPULSE TOBRAMYCIN ASSAY REAGENTS
    K840853 IMMPULSE TBC ASSAY REAGENTS
    K834070 IMMPULSE SYSTEM