BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    GlucoSure HT Plus Blood Glucose Monitoring System

    K Number: K202885 · Decision Sep 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    178
    Same Product Code
    506
    Applicant Total
    5
    Review Days
    352

    Basic Information

    Device Name
    GlucoSure HT Plus Blood Glucose Monitoring System
    K Number
    K202885
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apex BioTechnology Corp.
    Date Received
    September 28, 2020
    Decision Date
    September 15, 2021
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

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