BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

    K Number: K070452 · Decision May 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    82
    Review Days
    80

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    Basic Information

    Device Name
    VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
    K Number
    K070452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    February 16, 2007
    Decision Date
    May 7, 2007
    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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