BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SENTINEL LITHIUM ASSAY

    K Number: K070987 · Decision Aug 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    6
    Applicant Total
    12
    Review Days
    118

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    Basic Information

    Device Name
    SENTINEL LITHIUM ASSAY
    K Number
    K070987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SENTINEL CH. SpA
    Date Received
    April 6, 2007
    Decision Date
    August 2, 2007
    Product Code
    NDW
    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
    NDW Assay, Porphyrin, Spectrophotometry, Lithium

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