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

    T3-SQUIBB RIA KIT

    K Number: K802883 · Decision Dec 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    32
    Review Days
    32

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    Basic Information

    Device Name
    T3-SQUIBB RIA KIT
    K Number
    K802883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E. R. Squibb & Sons, Inc.
    Date Received
    November 17, 1980
    Decision Date
    December 19, 1980
    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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    Other Clearances by E. R. Squibb & Sons, Inc.

    K Number Device Name
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    K820341 CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
    K811240 SUR-FIT LOOP OSTOMY O.R. SET
    K811239 SUR-FIT DISPOSABLE CONVEX INSERT
    K811160 SUR-FIT IRRIGATION SLEEVE
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    K810966 DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
    K810211 T3 RIA KIT
    Search all 32 clearances from E. R. Squibb & Sons, Inc. →