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

    MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K062195 · Decision Aug 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    42
    Review Days
    15

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K062195
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifescan, Inc.
    Date Received
    August 1, 2006
    Decision Date
    August 16, 2006
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NBW), ordered by most recent decision date.

    On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TeleRPM Gen2 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIGHTEST Blood Glucose Monitoring System Max Tel

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Lifescan, Inc.

    K Number Device Name
    K132618 ONETOUCH REVEAL
    K120558 ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
    K093745 ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
    K082590 SYMPHONY METER REMOTE
    K082513 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
    K081318 ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
    K073231 ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
    K072543 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
    K061118 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
    K053529 ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
    Search all 42 clearances from Lifescan, Inc. →