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

    VIDAS B.R.A.H.M.S. PCT (PCT)

    K Number: K162827 · Decision Feb 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    7
    Applicant Total
    251
    Review Days
    139

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    Basic Information

    Device Name
    VIDAS B.R.A.H.M.S. PCT (PCT)
    K Number
    K162827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    bioMerieux, Inc.
    Date Received
    October 7, 2016
    Decision Date
    February 23, 2017
    Product Code
    PRI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PRI Procalcitonin Assay

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