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

    T-3 UPTAKE KIT

    K Number: K760802 · Decision Oct 29, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    321
    Review Days
    17

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    Basic Information

    Device Name
    T-3 UPTAKE KIT
    K Number
    K760802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Products Corp.
    Date Received
    October 12, 1976
    Decision Date
    October 29, 1976
    Product Code
    KHQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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    K023304 IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
    K022603 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
    K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
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