BEUDAMED
    Product Code: PZI FDA class 2 21 CFR 862.1345

    Prescription Use Blood Glucose Meter For Near-Patient Testing

    Clinical Chemistry

    The Prescription Use Blood Glucose Meter For Near-Patient Testing is an in vitro diagnostic device intended for multiple-patient quantitative glucose determination across all hospital and professional healthcare settings, used for the identification and management of dysglycemia. It is classified as a Class 2 device under regulation 862.1345, requiring 510(k) premarket notification before marketing. The product code is PZI, and it falls within the Clinical Chemistry (CH) medical specialty. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    14
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    4
    Years Active
    12

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    Basic Information

    Product Code
    PZI
    Device Class
    FDA class 2
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 14 510(k) clearances via K numbers.

    K Number Device Name
    K252323 cobas pulse blood glucose monitoring system
    K221349 XPER Technology PREMIUM Pro Blood Glucose Monitoring System
    K220272 cobas pulse blood glucose monitoring system
    K232075 StatStrip Glucose Hospital Meter System
    K200788 Assure Titanium Blood Glucose Monitoring System
    K182552 StatStrip Xpress Glucose Hospital Meter System
    K182549 StatStrip Xpress 2 Glucose Hospital Meter System
    K181043 StatStrip Glucose Hospital Meter System
    K163490 StatStrip Xpress 2 Glucose Hospital Meter System
    K161856 StatStrip Xpress Glucose Hospital Meter System
    K152986 StatStrip Xpress 2 Glucose Hospital Meter System
    K150461 StatStrip Xpress Glucose Hospital Meter System
    K150281 StatStrip Glucose Hospital Meter
    K132121 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.