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

    IMMPULSE T4 ASSAY REAGENTS

    K Number: K840852 · Decision Apr 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    7
    Review Days
    54

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    Basic Information

    Device Name
    IMMPULSE T4 ASSAY REAGENTS
    K Number
    K840852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    February 24, 1984
    Decision Date
    April 18, 1984
    Product Code
    CDX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Paragon Diagnostics, Inc.

    K Number Device Name
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    K840847 IMMPULSE TOBRAMYCIN ASSAY REAGENTS
    K840853 IMMPULSE TBC ASSAY REAGENTS
    K834070 IMMPULSE SYSTEM