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

    BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

    K Number: K991074 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    265

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    Basic Information

    Device Name
    BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
    K Number
    K991074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intracel Corp.
    Date Received
    March 31, 1999
    Decision Date
    December 21, 1999
    Product Code
    MJH
    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
    MJH Legionella, Spp., Elisa

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