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

    Lumipulse G TP-N Immunoreaction Cartridge Set

    K Number: K153145 · Decision Jul 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    34
    Applicant Total
    45
    Review Days
    249

    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
    Lumipulse G TP-N Immunoreaction Cartridge Set
    K Number
    K153145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    October 30, 2015
    Decision Date
    July 5, 2016
    Product Code
    LIP
    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
    LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

    Similar 510(k) Clearances

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

    Access Syphilis

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VITROS Immunodiagnostic Products Syphilis Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys Syphilis

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys Syphilis

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

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

    Other Clearances by Fujirebio Diagnostics,Inc.

    K Number Device Name
    K250925 ADVIA Centaur Cytokeratin Fragment 21-1
    K242706 Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
    DEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)
    K192524 Lumipulse G CA15-3
    K192380 ST AIA-PACK BNP
    K200997 Lumipulse G CA19-9-N
    K190702 Lumipulse G whole PTH
    K172713 Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
    K171103 Lumipulse G TSH-III Immunoreaction Cartridges
    K163546 Lumipulse G Progesterone-N Calibrators
    Search all 45 clearances from Fujirebio Diagnostics,Inc. →