BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MULTICHEM U

    K Number: K131993 · Decision Oct 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    6
    Review Days
    109

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    Basic Information

    Device Name
    MULTICHEM U
    K Number
    K131993
    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 , Ltd.
    Date Received
    June 28, 2013
    Decision Date
    October 15, 2013
    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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    Other Clearances by Techno-Path Manufacturing , Ltd.

    K Number Device Name
    K242492 Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
    K132751 MULTICHEM S PLUS / S PLUS (ASSAYED)
    K131992 MULTICHEM P
    K132174 MULTICHEM WBT
    K132091 MULTICHEM IA AND IA PLUS