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

    SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

    K Number: K140827 · Decision Sep 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    2
    Review Days
    547

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    Basic Information

    Device Name
    SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
    K Number
    K140827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sd Biosensor, Inc.
    Date Received
    April 1, 2014
    Decision Date
    September 30, 2015
    Product Code
    LCP
    Advisory Committee
    Hematology
    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
    LCP Assay, Glycosylated Hemoglobin

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    Other Clearances by Sd Biosensor, Inc.

    K Number Device Name
    K132929 SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM