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

    PICCOLO CHLORIDE TEST SYSTEM

    K Number: K010670 · Decision Apr 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    52
    Applicant Total
    20
    Review Days
    51

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    Basic Information

    Device Name
    PICCOLO CHLORIDE TEST SYSTEM
    K Number
    K010670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abaxis, Inc.
    Date Received
    March 6, 2001
    Decision Date
    April 26, 2001
    Product Code
    CHJ
    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
    CHJ Mercuric Thiocyanate, Colorimetry, Chloride

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