Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fujirebio Diagnostics,Inc. — Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
329 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025-12-16 | 264 | 0 |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | 2025-05-16 | 249 | 7 |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | 2022-05-04 | 530 | 0 |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | 2020-09-04 | 357 | 0 |
| K192380 | ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. | 2020-08-24 | 360 | 0 |
| K200997 | Lumipulse G CA19-9-N | Fujirebio Diagnostics,Inc. | 2020-05-14 | 28 | 0 |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | 2019-08-30 | 165 | 0 |
| K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumip | Fujirebio Diagnostics,Inc. | 2017-12-10 | 93 | 0 |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | 2017-07-28 | 106 | 0 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 | 28 | 0 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 | 28 | 0 |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017-01-12 | 27 | 0 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 | 28 | 0 |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016-12-01 | 30 | 0 |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | 2016-07-05 | 249 | 0 |
| K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | 2016-05-16 | 122 | 0 |
| K151502 | ARCHITECT ROMA | Fujirebio Diagnostics,Inc. | 2016-04-28 | 329 | 0 |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Cal | Fujirebio Diagnostics,Inc. | 2016-04-15 | 147 | 0 |
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 C | Fujirebio Diagnostics,Inc. | 2015-11-24 | 186 | 0 |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction | Fujirebio Diagnostics,Inc. | 2015-05-21 | 230 | 0 |
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIB | Fujirebio Diagnostics,Inc. | 2014-12-23 | 305 | 0 |
| K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO | Fujirebio Diagnostics,Inc. | 2014-01-17 | 92 | 0 |
| K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA | Fujirebio Diagnostics,Inc. | 2013-01-17 | 55 | 0 |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Fujirebio Diagnostics,Inc. | 2011-09-01 | 289 | 0 |
| K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | Fujirebio Diagnostics,Inc. | 2011-07-19 | 215 | 0 |
| K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL | Fujirebio Diagnostics,Inc. | 2011-05-27 | 84 | 0 |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | Fujirebio Diagnostics,Inc. | 2011-05-26 | 428 | 0 |
| K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA | Fujirebio Diagnostics,Inc. | 2011-04-20 | 64 | 0 |
| K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE | Fujirebio Diagnostics,Inc. | 2011-01-25 | 62 | 0 |
| K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 | Fujirebio Diagnostics,Inc. | 2010-10-05 | 98 | 0 |
| K102260 | FDI GLUCOSE CONTROL SOLUTIONS | Fujirebio Diagnostics,Inc. | 2010-09-24 | 45 | 0 |
| K093957 | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 C | Fujirebio Diagnostics,Inc. | 2010-03-18 | 85 | 0 |
| K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 | Fujirebio Diagnostics,Inc. | 2009-09-05 | 9 | 0 |
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | 2008-09-11 | 177 | 1 |
| K072939 | HE4 EIA, MODEL: 404-10 US | Fujirebio Diagnostics,Inc. | 2008-06-09 | 236 | 0 |
| K070822 | ARCHITECT SIROLIMUS ASSAY | Fujirebio Diagnostics,Inc. | 2007-09-28 | 186 | 1 |
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | Fujirebio Diagnostics,Inc. | 2007-08-01 | 128 | 1 |
| K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 | Fujirebio Diagnostics,Inc. | 2006-05-25 | 48 | 0 |
| K052889 | VITROS CA 19-9 | Fujirebio Diagnostics,Inc. | 2005-12-20 | 68 | 0 |
| K052000 | ARCHITECT CA 19-9XR ASSAY | Fujirebio Diagnostics,Inc. | 2005-10-25 | 92 | 1 |
| K042732 | ARCHITECT CA 15-3 ASSAY | Fujirebio Diagnostics,Inc. | 2004-12-22 | 82 | 0 |
| K042731 | ARCHITECT CA 125 II ASSAY | Fujirebio Diagnostics,Inc. | 2004-11-19 | 49 | 0 |
| K033731 | AXSYM CORTISOL ASSAY | Fujirebio Diagnostics,Inc. | 2004-02-20 | 84 | 0 |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | Fujirebio Diagnostics,Inc. | 2002-05-09 | 78 | 0 |
| K893124 | OLYMPUS PK(TM) TP | Fujirebio Diagnostics,Inc. | 1989-11-17 | 206 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda