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

    GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

    K Number: K121433 · Decision Feb 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    68
    Same Product Code
    72
    Applicant Total
    10
    Review Days
    276

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    Basic Information

    Device Name
    GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
    K Number
    K121433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hmd Biomedical, Inc.
    Date Received
    May 14, 2012
    Decision Date
    February 14, 2013
    Product Code
    LFR
    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
    LFR Glucose Dehydrogenase, Glucose

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    K131173 FIA Blood Glucose Monitoring System (G2)
    K113314 PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
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