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

    Atellica IM BRAHMS Procalcitonin (PCT)

    K Number: K181002 · Decision Jul 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    4
    Applicant Total
    152
    Review Days
    91

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    Basic Information

    Device Name
    Atellica IM BRAHMS Procalcitonin (PCT)
    K Number
    K181002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    April 16, 2018
    Decision Date
    July 16, 2018
    Product Code
    PMT
    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
    PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

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