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

    Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

    K Number: K170079 · Decision Oct 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    13
    Review Days
    269

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    Basic Information

    Device Name
    Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
    K Number
    K170079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyson Bioresearch, Inc.
    Date Received
    January 10, 2017
    Decision Date
    October 6, 2017
    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 Tyson Bioresearch, Inc.

    K Number Device Name
    K182046 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
    K182047 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
    K123087 TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
    K112916 TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
    K101543 TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
    K090629 EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
    K081726 TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
    K072854 DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
    K073492 DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
    K072441 EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
    Search all 13 clearances from Tyson Bioresearch, Inc. →