# Fujirebio Diagnostics,Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 45 (1989–2025): 44 510(k) clearances and 1 De Novo grant
- Product codes: JJX (7), JIT (5), OIU (4), NIG (4), ONX (3), OVK (2), NBC (2), LTK (2), MOI (2), CEW (1), OSX (1), JFT (1)
- 510(k) review time since 2016: median 93 days, against 92 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 41 (12 its own); citations of its devices by later devices: 32 (12 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 7 (https://510kreport.com/company/roche-diagnostics)
- Abbott Laboratories: 6 (https://510kreport.com/company/abbott-laboratories)
- DiaSorin, Inc.: 2 (https://510kreport.com/company/diasorin)
- Bio-Rad Laboratories, Inc.: 2 (https://510kreport.com/company/bio-rad-laboratories)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)
- Bayer Corp.: 1 (https://510kreport.com/company/bayer)
- Bg Medicine, Inc.: 1 (https://510kreport.com/company/bg-medicine)
- Home Diagnostics, Inc.: 1 (https://510kreport.com/company/home-diagnostics)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 7 (https://510kreport.com/company/roche-diagnostics)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)
- Shanghai Genext Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-genext-medical-technology)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Tosoh Bioscience, Inc.: 1 (https://510kreport.com/company/tosoh-bioscience)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Fujirebio Dianostics, Inc.: 1 (https://510kreport.com/company/fujirebio-dianostics)

## Its most-cited devices
- K020566: Fujirebio Diagnostics CA 19-9 Ria (2002), cited by 5
- DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40) (2022), cited by 4
- K070820: Architect Tacrolimus: Model 1L77 (2007), cited by 4
- K072939: HE4 Eia, Model: 404-10 US (2008), cited by 3
- K103358: Roma (HE4 Eia + Architect CA 125 II) (2011), cited by 3
- K100831: Cyfra 21-1 Eia Model 211-10 (2011), cited by 2

## Recent decisions
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (Dec 16, 2025)
- K242706: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (May 16, 2025)
- DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40) (May 4, 2022)
- K192524: Lumipulse G CA15-3 (Sep 4, 2020)
- K192380: ST Aia-Pack BNP (Aug 24, 2020)
- K200997: Lumipulse G CA19-9-N (May 14, 2020)
- K190702: Lumipulse G whole PTH (Aug 30, 2019)
- K172713: Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set (Dec 10, 2017)

Source page: https://510kreport.com/company/fujirebio-diagnostics