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

    SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM

    K Number: K130138 · Decision Mar 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    264
    Review Days
    56

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    Basic Information

    Device Name
    SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
    K Number
    K130138
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    January 18, 2013
    Decision Date
    March 15, 2013
    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

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