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

    Stat Profile Prime Plus Analyzer System

    K Number: K200204 · Decision Apr 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    40
    Review Days
    69

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    Basic Information

    Device Name
    Stat Profile Prime Plus Analyzer System
    K Number
    K200204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nova Biomedical Corporation
    Date Received
    January 28, 2020
    Decision Date
    April 6, 2020
    Product Code
    GGZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGZ Oxyhemoglobin

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