BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    B R A H M S PCT sensitive KRYPTOR

    K Number: K171338 · Decision May 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    B R A H M S PCT sensitive KRYPTOR
    K Number
    K171338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brahms GmbH
    Date Received
    May 8, 2017
    Decision Date
    May 31, 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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    Other Clearances by Brahms GmbH

    K Number Device Name
    DEN150009 B.R.A.H.M.S PCT sensitive KRYPTOR