BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMS GLUCOSE CONTROL, MODEL 2120061

    K Number: K070649 · Decision Apr 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    280
    Registration Numbers
    280
    Same Product Code
    492
    Applicant Total
    1
    Review Days
    35

    Basic Information

    Device Name
    SMS GLUCOSE CONTROL, MODEL 2120061
    K Number
    K070649
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SPECTRUM MEDICAL SUPPLY, INC.
    Date Received
    March 8, 2007
    Decision Date
    April 12, 2007
    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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