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

    IQ 200 URINE ANALIZER BODY FLUIDS MODULE

    K Number: K091539 · Decision Aug 31, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    2
    Review Days
    462

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    Basic Information

    Device Name
    IQ 200 URINE ANALIZER BODY FLUIDS MODULE
    K Number
    K091539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iris Diagnostics
    Date Received
    May 26, 2009
    Decision Date
    August 31, 2010
    Product Code
    GKL
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GKL Counter, Cell, Automated (Particle Counter)

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    Other Clearances by Iris Diagnostics

    K Number Device Name
    K072640 IRISPEC,CA/CB/CC