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

    REAGENT, THYROXINE T4 (#210)

    K Number: K760079 · Decision Jul 20, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    9
    Review Days
    32

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    Basic Information

    Device Name
    REAGENT, THYROXINE T4 (#210)
    K Number
    K760079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Oxford Laboratories, Inc.
    Date Received
    June 18, 1976
    Decision Date
    July 20, 1976
    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 Oxford Laboratories, Inc.

    K Number Device Name
    K780912 ADJUSTABLE DISPENSOR
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    K760143 SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
    K760144 SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID
    K760146 SERUM, IGA GOAT ANTI-HUMAN ACID
    K760148 SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
    K760145 SERUM, IGG GOAT ANTI-HUMAN ACID