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

    B-R-A-H-M-S PCT LIA

    K Number: K040887 · Decision Jan 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    277

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    Basic Information

    Device Name
    B-R-A-H-M-S PCT LIA
    K Number
    K040887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3210
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brahms Aktiengesellschaft
    Date Received
    April 5, 2004
    Decision Date
    January 7, 2005
    Product Code
    NTM
    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
    NTM Antigen, Inflammatory Response Marker, Sepsis

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    Other Clearances by Brahms Aktiengesellschaft

    K Number Device Name
    K070310 B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM