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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    BC-3600 Auto Hematology Analyzer

    K Number: K143348 · Decision Aug 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    2
    Review Days
    273

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    Basic Information

    Device Name
    BC-3600 Auto Hematology Analyzer
    K Number
    K143348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mindray Bio-Medical Electronics Co., Ltd.
    Date Received
    November 21, 2014
    Decision Date
    August 21, 2015
    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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