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

    ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090

    K Number: K090854 · Decision Apr 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    4
    Review Days
    17

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    Basic Information

    Device Name
    ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
    K Number
    K090854
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Biological Technologies, Inc.
    Date Received
    March 30, 2009
    Decision Date
    April 16, 2009
    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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    Other Clearances by American Biological Technologies, Inc.

    K Number Device Name
    K091460 ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
    K090943 ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
    K083549 ABT GLUCOSE CONTROL SOLUTION