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 a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2025-05-16 under approval 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. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K242706.
When was Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio approved by the FDA?
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio received FDA 510(k) clearance on 2025-05-16, under approval number K242706.
What company makes Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio?
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is manufactured by Fujirebio Diagnostics,Inc..
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.