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

    DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K130244 · Decision Aug 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    7
    Review Days
    204

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    Basic Information

    Device Name
    DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K130244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Delbio Incorporation
    Date Received
    January 31, 2013
    Decision Date
    August 23, 2013
    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 Delbio Incorporation

    K Number Device Name
    K133090 OXICARE FINGERTIP PULSE OXIMETER
    K132338 DA01 BLOOD GLUCOSE MONITORING SYSTEM
    K120866 DA01 BLOOD GLUCOSE MONITORING SYSTEM
    K103329 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
    K113343 DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
    K100806 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM