BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY

    K Number: K000884 · Decision Jan 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    305

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    Basic Information

    Device Name
    BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
    K Number
    K000884
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3370
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Biosciences
    Date Received
    March 20, 2000
    Decision Date
    January 19, 2001
    Product Code
    NDZ
    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
    NDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis