BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMPULSE SYSTEM

    K Number: K834070 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    13
    Applicant Total
    7
    Review Days
    119

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    Basic Information

    Device Name
    IMMPULSE SYSTEM
    K Number
    K834070
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    November 25, 1983
    Decision Date
    March 23, 1984
    Product Code
    JZT
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JZT Fluorometer

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    Other Clearances by Paragon Diagnostics, Inc.

    K Number Device Name
    K841161 IMMPULSE AMIKACIN ASSAY REAGENTS
    K841162 IMMPULSE GENTAMICIN ASSAY REAGENTS
    K840852 IMMPULSE T4 ASSAY REAGENTS
    K840758 IMMPULSE THEOPHYLLINE ASSAY REAGENTS
    K840847 IMMPULSE TOBRAMYCIN ASSAY REAGENTS
    K840853 IMMPULSE TBC ASSAY REAGENTS