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

    LEGIONELLA PNEUMOPHILA IGG/IGM

    K Number: K033051 · Decision Nov 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    9
    Applicant Total
    11
    Review Days
    58

    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
    LEGIONELLA PNEUMOPHILA IGG/IGM
    K Number
    K033051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Biotech USA
    Date Received
    September 29, 2003
    Decision Date
    November 26, 2003
    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

    Similar 510(k) Clearances

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

    ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRU Legionella

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRU LEGIONELLA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

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

    Other Clearances by Trinity Biotech USA

    K Number Device Name
    K140455 CAPTIA MEASLES IGM
    K033105 CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
    K033106 CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
    K033070 BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
    K033079 CHLAMYDIA IGG ELISA TEST SYSTEM
    K033067 PYLORI IGG
    K033064 MYCOPLASMA IGG
    K033083 BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
    K993839 ENA PROFILE ELISA TEST SYSTEM
    K992665 MACRA LP(A) ENZYME IMMUNOASSAY KIT
    Search all 11 clearances from Trinity Biotech USA →