BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IRISPEC,CA/CB/CC

    K Number: K072640 · Decision Dec 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    IRISPEC,CA/CB/CC
    K Number
    K072640
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iris Diagnostics
    Date Received
    September 18, 2007
    Decision Date
    December 21, 2007
    Product Code
    JJW
    Advisory Committee
    Clinical Chemistry
    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
    JJW Urinalysis Controls (Assayed And Unassayed)

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