Company · US
Fujirebio Diagnostics,Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2025. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (1 in 12 months)
8recalls (7 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| SET | Immunoassay Blood Test For Amyloid Pathology Assessment | 8 |
| 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 |
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | 4 |
| ONX | Ovarian Adnexal Mass Assessment Score Test System | 3 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 |
| MOI | System, Test, Immunological, Antigen, Tumor | 2 |
| NBC | Test, Natriuretic Peptide | 2 |
| OVK | Cytokeratin Fragments 21-1 Eia Kit | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| GMT | Antigens, Ha, Treponema Pallidum | 1 |
| JFT | Fluorometric, Cortisol | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 1 |
| MKW | Cyclosporine | 1 |
| MLM | Enzyme Immunoassay, Tracrolimus | 1 |
| MRG | System, Test, Vitamin D | 1 |
| NRP | Sirolimus Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2025 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 Fujirebio Diagnostics,Inc. | OVK |
| May 16, 2025 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio Fujirebio Diagnostics,Inc. | SET |
| May 4, 2022 | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics,Inc. | QSE |
| Sep 4, 2020 | K192524 | Lumipulse G CA15-3 Fujirebio Diagnostics,Inc. | MOI |
| Aug 24, 2020 | K192380 | ST AIA-PACK BNP Fujirebio Diagnostics,Inc. | NBC |
| May 14, 2020 | K200997 | Lumipulse G CA19-9-N Fujirebio Diagnostics,Inc. | NIG |
| Aug 30, 2019 | K190702 | Lumipulse G whole PTH Fujirebio Diagnostics,Inc. | CEW |
| Dec 10, 2017 | K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set Fujirebio Diagnostics,Inc. | PRI |
| Jul 28, 2017 | K171103 | Lumipulse G TSH-III Immunoreaction Cartridges Fujirebio Diagnostics,Inc. | JLW |
| Jan 13, 2017 | K163546 | Lumipulse G Progesterone-N Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Jan 13, 2017 | K163534 | Lumipulse G FSH-N Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Jan 12, 2017 | K163544 | Lumipulse G Prolactin Fujirebio Diagnostics,Inc. | JIT |
| Jan 12, 2017 | K163521 | Lumipulse G LH Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Dec 1, 2016 | K163053 | Lumipulse G E2-III Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Jul 5, 2016 | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set Fujirebio Diagnostics,Inc. | LIP |
| May 16, 2016 | K160090 | Lumipulse G ROMA Fujirebio Diagnostics,Inc. | ONX |
| Apr 28, 2016 | K151502 | ARCHITECT ROMA Fujirebio Diagnostics,Inc. | ONX |
| Apr 15, 2016 | K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators Fujirebio Diagnostics,Inc. | MRG |
| Nov 24, 2015 | K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators Fujirebio Diagnostics,Inc. | OIU |
| May 21, 2015 | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators Fujirebio Diagnostics,Inc. | LTK |
| Dec 23, 2014 | K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS Fujirebio Diagnostics,Inc. | OSX |
| Jan 17, 2014 | K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE Fujirebio Diagnostics,Inc. | JJX |
| Jan 17, 2013 | K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA Fujirebio Diagnostics,Inc. | JJX |
| Sep 1, 2011 | K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) Fujirebio Diagnostics,Inc. | ONX |
| Jul 19, 2011 | K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL Fujirebio Diagnostics,Inc. | OIU |
| May 27, 2011 | K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL Fujirebio Diagnostics,Inc. | JJX |
| May 26, 2011 | K100831 | CYFRA 21-1 EIA MODEL 211-10 Fujirebio Diagnostics,Inc. | OVK |
| Apr 20, 2011 | K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA Fujirebio Diagnostics,Inc. | JJX |
| Jan 25, 2011 | K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE Fujirebio Diagnostics,Inc. | JJX |
| Oct 5, 2010 | K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 Fujirebio Diagnostics,Inc. | JJY |
| Sep 24, 2010 | K102260 | FDI GLUCOSE CONTROL SOLUTIONS Fujirebio Diagnostics,Inc. | JJX |
| Mar 18, 2010 | K093957 | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, Fujirebio Diagnostics,Inc. | OIU |
| Sep 5, 2009 | K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 Fujirebio Diagnostics,Inc. | JJX |
| Sep 11, 2008 | K080751 | ARCHITECT CYCLOSPORINE Fujirebio Diagnostics,Inc. | MKW |
| Jun 9, 2008 | K072939 | HE4 EIA, MODEL: 404-10 US Fujirebio Diagnostics,Inc. | OIU |
| Sep 28, 2007 | K070822 | ARCHITECT SIROLIMUS ASSAY Fujirebio Diagnostics,Inc. | NRP |
| Aug 1, 2007 | K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 Fujirebio Diagnostics,Inc. | MLM |
| May 25, 2006 | K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 Fujirebio Diagnostics,Inc. | NBC |
| Dec 20, 2005 | K052889 | VITROS CA 19-9 Fujirebio Diagnostics,Inc. | NIG |
| Oct 25, 2005 | K052000 | ARCHITECT CA 19-9XR ASSAY Fujirebio Diagnostics,Inc. | NIG |
| Dec 22, 2004 | K042732 | ARCHITECT CA 15-3 ASSAY Fujirebio Diagnostics,Inc. | MOI |
| Nov 19, 2004 | K042731 | ARCHITECT CA 125 II ASSAY Fujirebio Diagnostics,Inc. | LTK |
| Feb 20, 2004 | K033731 | AXSYM CORTISOL ASSAY Fujirebio Diagnostics,Inc. | JFT |
| May 9, 2002 | K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA Fujirebio Diagnostics,Inc. | NIG |
| Nov 17, 1989 | K893124 | OLYMPUS PK(TM) TP Fujirebio Diagnostics,Inc. | GMT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse -Amyloid Plasma Controls
Model/Catalog Number: 81559
Software Version: Not Applicable
Product Description: Lumipulse -Amyloid Plasma Controls:
This quality control product can Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators
Model/Catalog Number: 235454
Software Version: Not Applicable
Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators:
The -Amy Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges
Model/Catalog Number: 235447
Software Version: Not Applicable
Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunor Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse pTau 217 Plasma Controls
Model/Catalog Number: 81558
Software Version: Not Applicable
Product Description: Lumipulse pTau 217 Plasma Controls:
This quality control product can Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau 217 Plasma Calibrators
Model/Catalog Number: 81557
Software Version: Not Applicable
Product Description: Lumipulse G pTau 217 Plasma Calibrators:
The pTau 217 plasma con Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
Model/Catalog Number: 81550
Software Version: Not Applicable
Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartrid Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Model/Catalog Number: CL0073
Software Version: Not Applicable
Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in Open, Classified |
SET | K242706 |
| Mar 8, 2011 | Fujirebio Diagnostics, Inc. MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests.
MESOMARK is an enzyme linked immunosorbent Terminated |
OAW | None listed |