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

    MULTICHEM WBT

    K Number: K132174 · Decision Sep 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    MULTICHEM WBT
    K Number
    K132174
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techno-Path Manufacturing , Ltd.
    Date Received
    July 15, 2013
    Decision Date
    September 20, 2013
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIF Drug Mixture Control Materials

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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)
    K131993 MULTICHEM U
    K131992 MULTICHEM P
    K132091 MULTICHEM IA AND IA PLUS