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

    ABX PENTRA 60C+ HEMATOLOGY ANALYZER

    K Number: K003677 · Decision Dec 26, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    ABX PENTRA 60C+ HEMATOLOGY ANALYZER
    K Number
    K003677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abx Diagnostics
    Date Received
    November 29, 2000
    Decision Date
    December 26, 2000
    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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