BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

    K Number: K173139 · Decision Jun 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    21
    Review Days
    263

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    Basic Information

    Device Name
    Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
    K Number
    K173139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionime Corporation
    Date Received
    September 29, 2017
    Decision Date
    June 19, 2018
    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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    Other Clearances by Bionime Corporation

    K Number Device Name
    K240637 RIGHTEST Blood Glucose Monitoring System Max Tel
    K231192 RIGHTEST Blood Glucose Monitoring System Max Tel
    K221062 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
    K190564 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
    K173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
    K170143 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,
    K161790 iGlucose Blood Glucose Monitoring System
    K140210 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720
    K133003 RIGHTEST CONTROL SOLUTION
    K123008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
    Search all 21 clearances from Bionime Corporation →