510(k) K242706 · SET Immunoassay Blood Test For Amyloid Pathology Assessment
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Sep 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.