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

    EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277

    K Number: K100560 · Decision May 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
    K Number
    K100560
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotest Medical Corp.
    Date Received
    March 1, 2010
    Decision Date
    May 12, 2010
    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 Biotest Medical Corp.

    K Number Device Name
    K141351 SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K133509 EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
    K123559 SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
    K122525 SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K100701 SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
    K093764 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
    K091815 SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268