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

    ADVIA IMS LITHIUM ASSAY

    K Number: K050374 · Decision Jun 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    6
    Applicant Total
    46
    Review Days
    121

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    Basic Information

    Device Name
    ADVIA IMS LITHIUM ASSAY
    K Number
    K050374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Healthcare, LLC
    Date Received
    February 14, 2005
    Decision Date
    June 15, 2005
    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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