BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

    K Number: K060510 · Decision Jun 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    280
    Registration Numbers
    280
    Same Product Code
    492
    Applicant Total
    7
    Review Days
    112

    Basic Information

    Device Name
    DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
    K Number
    K060510
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DREW SCIENTIFIC LTD.
    Date Received
    February 27, 2006
    Decision Date
    June 19, 2006
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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