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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K131727 · Decision Feb 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    68
    Same Product Code
    72
    Applicant Total
    4
    Review Days
    261

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    Basic Information

    Device Name
    CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K131727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ceragem Medisys, Inc.
    Date Received
    June 12, 2013
    Decision Date
    February 28, 2014
    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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    Other Clearances by Ceragem Medisys, Inc.

    K Number Device Name
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    K102751 LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM