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

    ACCESS TOTAL T3 ASSAY (MODIFICATION)

    K Number: K955435 · Decision Jan 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    143
    Applicant Total
    78
    Review Days
    114

    Basic Information

    Device Name
    ACCESS TOTAL T3 ASSAY (MODIFICATION)
    K Number
    K955435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIO-RAD LABORATORIES, INC.
    Date Received
    October 2, 1995
    Decision Date
    January 24, 1996
    Product Code
    CDP
    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
    CDP Radioimmunoassay, Total Triiodothyronine

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