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

    Piccolo Potassium Test System

    K Number: K200865 · Decision Oct 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    20
    Review Days
    567

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    Basic Information

    Device Name
    Piccolo Potassium Test System
    K Number
    K200865
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abaxis, Inc.
    Date Received
    April 1, 2020
    Decision Date
    October 20, 2021
    Product Code
    MZV
    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
    MZV Test, System, Potassium, Enzymatic Method

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