FDA 510(k)

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio

N.º K: K242706 · 2025-05-16

Fecha de decisión2025-05-16

Código de productoSET

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K242706. The device is classified under product code SET. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio?

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K242706.

When did Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio receive FDA 510(k) clearance?

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio received FDA 510(k) clearance on 2025-05-16, under 510(k) number K242706.

Who is the listed applicant for Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio?

The FDA 510(k) record lists Fujirebio Diagnostics,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio?

The FDA product code for Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is SET.

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K250925ADVIA Centaur Fragmento de Citoqueratina 21-1 K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP K200997Lumipulse G CA19-9-N K190702Lumipulse G whole PTH K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set

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Fuente oficial

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