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

    StatStrip Glucose Hospital Meter System

    K Number: K232075 · Decision Feb 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    40
    Review Days
    226

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    Basic Information

    Device Name
    StatStrip Glucose Hospital Meter System
    K Number
    K232075
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nova Biomedical Corporation
    Date Received
    July 12, 2023
    Decision Date
    February 23, 2024
    Product Code
    PZI
    Advisory Committee
    Clinical Chemistry
    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
    PZI Prescription Use Blood Glucose Meter For Near-Patient Testing

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