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

    U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC

    K Number: K092902 · Decision Mar 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    123
    Review Days
    162

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
    K Number
    K092902
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taidoc Technology Corporation
    Date Received
    September 21, 2009
    Decision Date
    March 2, 2010
    Product Code
    NBW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NBW), ordered by most recent decision date.

    On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TeleRPM Gen2 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIGHTEST Blood Glucose Monitoring System Max Tel

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Taidoc Technology Corporation

    K Number Device Name
    K221349 XPER Technology PREMIUM Pro Blood Glucose Monitoring System
    K201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
    K200946 Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
    K190579 TD-4183 Blood Glucose Monitoring System
    K182934 FORA P100 Blood Pressure Monitoring System
    K180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
    K181675 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
    K181588 POPS! one Blood Glucose Monitoring System
    K172733 TD-1035 Thermometer
    K173511 ActiveCare TD-4121 Blood Glucose Monitoring System
    Search all 123 clearances from Taidoc Technology Corporation →