BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇪 Ireland

    Multichem IA Plus

    K Number: K162530 · Decision Mar 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    Multichem IA Plus
    K Number
    K162530
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techno-Path Manufacturing
    Date Received
    September 9, 2016
    Decision Date
    March 31, 2017
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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