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

    GLUCOSCAN CONTROLS

    K Number: K822698 · Decision Sep 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    42
    Review Days
    23

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    Basic Information

    Device Name
    GLUCOSCAN CONTROLS
    K Number
    K822698
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Lifescan, Inc.
    Date Received
    September 7, 1982
    Decision Date
    September 30, 1982
    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 Lifescan, Inc.

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    K082590 SYMPHONY METER REMOTE
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    K073231 ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
    K072543 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
    K062195 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    K061118 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
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