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

    DIGOXIN-EIA-XT

    K Number: K896863 · Decision Feb 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    15
    Review Days
    69

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    Basic Information

    Device Name
    DIGOXIN-EIA-XT
    K Number
    K896863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    In Vitro Diagnostics, Inc.
    Date Received
    December 6, 1989
    Decision Date
    February 13, 1990
    Product Code
    KXT
    Advisory Committee
    Clinical Toxicology
    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
    KXT Enzyme Immunoassay, Digoxin

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    Other Clearances by In Vitro Diagnostics, Inc.

    K Number Device Name
    K896867 THYROID STIMULATING HORMONE-EIA-XT
    K896866 LUTEINIZING HORMONE-EIA-XT
    K896865 VITRO T4-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. →