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

    DAC-CEL T4

    K Number: K791231 · Decision Sep 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    17
    Review Days
    64

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    Basic Information

    Device Name
    DAC-CEL T4
    K Number
    K791231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Burroughs Wellcome Co.
    Date Received
    July 2, 1979
    Decision Date
    September 4, 1979
    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 Burroughs Wellcome Co.

    K Number Device Name
    K820069 WELLCOGEN GROUP B
    K813508 SAC-CEL
    K810215 DAC-CEL HCG
    K810214 DAC-CEL DIAGNATAL
    K810213 DAC-CEL TSH
    K810212 DAC-CEL T3 UPTAKE
    K791232 DAC-CEL T3
    K781607 STREP-TEX
    K780873 THYMUNE-M
    K780874 THYMUNE-T
    Search all 17 clearances from Burroughs Wellcome Co. →