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

    VITRO T4-EIA-XT

    K Number: K896865 · Decision Jan 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    15
    Review Days
    55

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    Basic Information

    Device Name
    VITRO T4-EIA-XT
    K Number
    K896865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    In Vitro Diagnostics, Inc.
    Date Received
    December 6, 1989
    Decision Date
    January 30, 1990
    Product Code
    KLI
    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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    Other Clearances by In Vitro Diagnostics, Inc.

    K Number Device Name
    K896867 THYROID STIMULATING HORMONE-EIA-XT
    K896863 DIGOXIN-EIA-XT
    K896866 LUTEINIZING HORMONE-EIA-XT
    K896925 T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT
    K896864 FOLLICLE STIMULATING HORMONE-EIA-XT
    K873832 REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
    K871182 FLAME PHOTOMETER STANDARD #60081 120 NA/2K
    K871183 FLAME PHOTOMETER STANDARD #60082 140 NA/5K
    K871188 LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
    K871185 LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
    Search all 15 clearances from In Vitro Diagnostics, Inc. →