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

    MISSION U500 URINE ANALYZER

    K Number: K111221 · Decision Jan 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    10
    Applicant Total
    85
    Review Days
    261

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    Basic Information

    Device Name
    MISSION U500 URINE ANALYZER
    K Number
    K111221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ACON Laboratories, Inc.
    Date Received
    May 2, 2011
    Decision Date
    January 18, 2012
    Product Code
    JIO
    Advisory Committee
    Hematology
    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
    JIO Blood, Occult, Colorimetric, In Urine

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