Fujirebio Diagnostics,Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Fujirebio Diagnostics,Inc.” (first 1989, latest 2025), plus 1 De Novo decision, across 23 product codes in 4 review panels. Median 510(k) review time under this name: 96 days. Since 2017 the median was 100 days, against 145 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 55 |
| 2014 | 2 | 198 |
| 2015 | 2 | 208 |
| 2016 | 5 | 147 |
| 2017 | 6 | 28 |
| 2018 | 0 | — |
| 2019 | 1 | 165 |
| 2020 | 3 | 357 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 256 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fujirebio Diagnostics,Inc. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 7 | 7 |
| JIT | Calibrator, Secondary | 5 | 5 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 4 | 4 |
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | 4 | 4 |
| ONX | Ovarian Adnexal Mass Assessment Score Test System | 3 | 3 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | 2 |
| MOI | System, Test, Immunological, Antigen, Tumor | 2 | 2 |
| NBC | Test, Natriuretic Peptide | 2 | 2 |
| OVK | Cytokeratin Fragments 21-1 Eia Kit | 2 | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
Plus 13 more product codes.
Review panels
- Clinical Chemistry (20)
- Immunology (19)
- Microbiology (3)
- Clinical Toxicology (3)
Most recent Fujirebio Diagnostics,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | OVK | 2025-12-16 | 264 |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | SET | 2025-05-16 | 249 |
| K192524 | Lumipulse G CA15-3 | MOI | 2020-09-04 | 357 |
| K192380 | ST AIA-PACK BNP | NBC | 2020-08-24 | 360 |
| K200997 | Lumipulse G CA19-9-N | NIG | 2020-05-14 | 28 |
| K190702 | Lumipulse G whole PTH | CEW | 2019-08-30 | 165 |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set | PRI | 2017-12-10 | 93 |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | JLW | 2017-07-28 | 106 |
| K163546 | Lumipulse G Progesterone-N Calibrators | JIT | 2017-01-13 | 28 |
| K163534 | Lumipulse G FSH-N Calibrators | JIT | 2017-01-13 | 28 |
34 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200072 | De Novo | AlzheimerS Disease Pathology Assessment Test | 2022-05-04 |
Recalls
8 product recalls in 2 recall events; 7 initiated in the last five years. Most recent: 2025-12-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Fujirebio Diagnostics,Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02614209: Blood Collection of Patient Presenting in the ED and Prescribed a BNP (Completed, started 2015-05)
- NCT02614170: A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals (Completed, started 2015-03)
- NCT02270931: A Prospective Longitudinal Breast Cancer Study (Completed, started 2014-05)
- NCT00315692: Risk of Ovarian Cancer in Patients With a Pelvic Mass (Completed, started 2005-12)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fujirebio America, Inc. (2 510(k)s)
- Fujirebio Diagnostics Texas, Inc. (2 510(k)s)
- Fujirebio Dianostics, Inc. (1 510(k)s)
- Fujirebio Europe N.V. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fujirebio Diagnostics,Inc.?
FDA lists 44 510(k) clearances under the applicant name “Fujirebio Diagnostics,Inc.” (first 1989, latest 2025), plus 1 De Novo decision, across 23 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fujirebio Diagnostics,Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fujirebio Diagnostics,Inc. is 96 days. Since 2017: 100 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fujirebio Diagnostics,Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 7); JIT (Calibrator, Secondary, 5); NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer, 4).
Next steps
- See all 44 Fujirebio Diagnostics,Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Fujirebio Diagnostics,Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.