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

    DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

    K Number: K112142 · Decision Nov 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    6
    Applicant Total
    92
    Review Days
    101

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    Basic Information

    Device Name
    DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
    K Number
    K112142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics
    Date Received
    July 26, 2011
    Decision Date
    November 4, 2011
    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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