BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    CHEMPAQ XBC ANALYZER

    K Number: K090013 · Decision Apr 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    2
    Review Days
    109

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    Basic Information

    Device Name
    CHEMPAQ XBC ANALYZER
    K Number
    K090013
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chempaq A/S
    Date Received
    January 2, 2009
    Decision Date
    April 21, 2009
    Product Code
    GKZ
    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
    GKZ Counter, Differential Cell

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