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

    ABL80 FLEX and ABL80 FLEX CO-OX

    K Number: K151639 · Decision Dec 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    172

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    Basic Information

    Device Name
    ABL80 FLEX and ABL80 FLEX CO-OX
    K Number
    K151639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sendx Medical, Inc.
    Date Received
    June 18, 2015
    Decision Date
    December 7, 2015
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

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