BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇩🇪 Germany

    B.R.A.H.M.S PCT sensitive KRYPTOR

    K Number: DEN150009 · Decision Feb 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    353

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    B.R.A.H.M.S PCT sensitive KRYPTOR
    K Number
    DEN150009
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Brahms GmbH
    Date Received
    March 4, 2015
    Decision Date
    February 20, 2016
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PMT), ordered by most recent decision date.

    VITROS BRAHMS PCT Reagent Pack and Calibrators

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Atellica IM BRAHMS Procalcitonin (PCT)

    FDA 510(k)
    FDA Class 2 ·Microbiology

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

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Brahms GmbH

    K Number Device Name
    K171338 B R A H M S PCT sensitive KRYPTOR