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

    MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

    K Number: K050338 · Decision Mar 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    21

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    Basic Information

    Device Name
    MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
    K Number
    K050338
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Akers Biosciences, Inc.
    Date Received
    February 11, 2005
    Decision Date
    March 4, 2005
    Product Code
    JIH
    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
    JIH Flame Photometry, Lithium

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