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Fujirebio Diagnostics,Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories12
Latest FDA decision2025-12-16
TypeNumberDevice NameCodeDateActions
510(k) K250925 ADVIA Centaur Cytokeratin Fragment 21-1OVK2025-12-16 View
510(k) K242706 Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET2025-05-16 View
510(k) K192524 Lumipulse G CA15-3MOI2020-09-04 View
510(k) K192380 ST AIA-PACK BNPNBC2020-08-24 View
510(k) K200997 Lumipulse G CA19-9-NNIG2020-05-14 View
510(k) K190702 Lumipulse G whole PTHCEW2019-08-30 View
510(k) K172713 Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setPRI2017-12-10 View
510(k) K171103 Lumipulse G TSH-III Immunoreaction CartridgesJLW2017-07-28 View
510(k) K163534 Lumipulse G FSH-N CalibratorsJIT2017-01-13 View
510(k) K163546 Lumipulse G Progesterone-N CalibratorsJIT2017-01-13 View
510(k) K163521 Lumipulse G LH CalibratorsJIT2017-01-12 View
510(k) K163544 Lumipulse G ProlactinJIT2017-01-12 View
510(k) K163053 Lumipulse G E2-III CalibratorsJIT2016-12-01 View
510(k) K153145 Lumipulse G TP-N Immunoreaction Cartridge SetLIP2016-07-05 View
510(k) K160090 Lumipulse G ROMAONX2016-05-16 View
510(k) K151502 ARCHITECT ROMAONX2016-04-28 View
510(k) K153361 Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsMRG2016-04-15 View
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