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

    DIAZYME LITHIUM ENZYMATIC ASSAY KIT

    K Number: K033360 · Decision Dec 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    DIAZYME LITHIUM ENZYMATIC ASSAY KIT
    K Number
    K033360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Atomics
    Date Received
    October 21, 2003
    Decision Date
    December 23, 2003
    Product Code
    JII
    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
    JII Atomic Absorption, Lithium

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