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

    CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

    K Number: K102778 · Decision Sep 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    34
    Applicant Total
    7
    Review Days
    357

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    Basic Information

    Device Name
    CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
    K Number
    K102778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CellaVision AB
    Date Received
    September 24, 2010
    Decision Date
    September 16, 2011
    Product Code
    JOY
    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
    JOY Device, Automated Cell-Locating

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    Other Clearances by CellaVision AB

    K Number Device Name
    K200595 CellaVision DC-1, CellaVision DC-1 PPA
    K171315 Advanced RBC Application
    K092868 CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
    K080595 CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
    K033840 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
    K003301 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER