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

    Cito CBC System

    K Number: K240402 · Decision Feb 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    1
    Review Days
    360

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    Basic Information

    Device Name
    Cito CBC System
    K Number
    K240402
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytochip, Inc.
    Date Received
    February 9, 2024
    Decision Date
    February 3, 2025
    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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