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

    LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901

    K Number: K003583 · Decision Jan 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    6
    Applicant Total
    22
    Review Days
    58

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    Basic Information

    Device Name
    LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
    K Number
    K003583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trace America, Inc.
    Date Received
    November 20, 2000
    Decision Date
    January 17, 2001
    Product Code
    NDW
    Advisory Committee
    Clinical Toxicology
    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
    NDW Assay, Porphyrin, Spectrophotometry, Lithium

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