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

    T3 UPTAKE-SQUIBB DIAGNOSTIC KIT

    K Number: K820340 · Decision Mar 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    32
    Review Days
    24

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    Basic Information

    Device Name
    T3 UPTAKE-SQUIBB DIAGNOSTIC KIT
    K Number
    K820340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E. R. Squibb & Sons, Inc.
    Date Received
    February 8, 1982
    Decision Date
    March 4, 1982
    Product Code
    KHQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KHQ Radioassay, Triiodothyronine Uptake

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    K811240 SUR-FIT LOOP OSTOMY O.R. SET
    K811239 SUR-FIT DISPOSABLE CONVEX INSERT
    K811160 SUR-FIT IRRIGATION SLEEVE
    K811163 SUR-FIT DISPOSABLE FANGE CAP
    K810966 DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
    K810211 T3 RIA KIT
    K803100 STOMAHESIVE PASTE PROTECTIVE SKIN BARR
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