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

    cobas pulse blood glucose monitoring system

    K Number: K252323 · Decision Jun 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    183
    Review Days
    322

    Basic Information

    Device Name
    cobas pulse blood glucose monitoring system
    K Number
    K252323
    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
    Roche Diagnostics
    Date Received
    July 25, 2025
    Decision Date
    June 12, 2026
    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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