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

    TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

    K Number: K932980 · Decision Oct 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    164
    Review Days
    123

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    Basic Information

    Device Name
    TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
    K Number
    K932980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    June 17, 1993
    Decision Date
    October 18, 1993
    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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