Fujirebio Diagnostics,Inc.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories13
Latest Approval2025-12-16
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | OVK | 2025-12-16 | View |
| 510(k) | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | SET | 2025-05-16 | View |
| 510(k) | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | QSE | 2022-05-04 | View |
| 510(k) | K192524 | Lumipulse G CA15-3 | MOI | 2020-09-04 | View |
| 510(k) | K192380 | ST AIA-PACK BNP | NBC | 2020-08-24 | View |
| 510(k) | K200997 | Lumipulse G CA19-9-N | NIG | 2020-05-14 | View |
| 510(k) | K190702 | Lumipulse G whole PTH | CEW | 2019-08-30 | View |
| 510(k) | K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set | PRI | 2017-12-10 | View |
| 510(k) | K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | JLW | 2017-07-28 | View |
| 510(k) | K163534 | Lumipulse G FSH-N Calibrators | JIT | 2017-01-13 | View |
| 510(k) | K163546 | Lumipulse G Progesterone-N Calibrators | JIT | 2017-01-13 | View |
| 510(k) | K163521 | Lumipulse G LH Calibrators | JIT | 2017-01-12 | View |
| 510(k) | K163544 | Lumipulse G Prolactin | JIT | 2017-01-12 | View |
| 510(k) | K163053 | Lumipulse G E2-III Calibrators | JIT | 2016-12-01 | View |
| 510(k) | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | LIP | 2016-07-05 | View |
| 510(k) | K160090 | Lumipulse G ROMA | ONX | 2016-05-16 | View |
| 510(k) | K151502 | ARCHITECT ROMA | ONX | 2016-04-28 | View |
| 510(k) | K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | MRG | 2016-04-15 | View |
No matching devices.