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FDA 510(k)

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

K-Number: K242706 · 2025-05-16

ApplicantFujirebio Diagnostics,Inc.
Decision Date2025-05-16
Product CodeSET
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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