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

    ROCHE COBAS TAQMAN ANALYZER

    K Number: K012966 · Decision Feb 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    56
    Applicant Total
    51
    Review Days
    150

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    Basic Information

    Device Name
    ROCHE COBAS TAQMAN ANALYZER
    K Number
    K012966
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    September 4, 2001
    Decision Date
    February 1, 2002
    Product Code
    JJF
    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
    JJF Analyzer, Chemistry, Micro, For Clinical Use

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