Elecsys Phospho-Tau (181P) Plasma
K-Number: K252163 · 2025-10-08
ApplicantRoche Diagnostics
Decision Date2025-10-08
Product CodeSET
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Elecsys Phospho-Tau (181P) Plasma is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2025-10-08 under approval number K252163. 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 Elecsys Phospho-Tau (181P) Plasma?
Elecsys Phospho-Tau (181P) Plasma is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Roche Diagnostics. The 510(k) number is K252163.
When was Elecsys Phospho-Tau (181P) Plasma approved by the FDA?
Elecsys Phospho-Tau (181P) Plasma received FDA 510(k) clearance on 2025-10-08, under approval number K252163.
What company makes Elecsys Phospho-Tau (181P) Plasma?
Elecsys Phospho-Tau (181P) Plasma is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Phospho-Tau (181P) Plasma?
The FDA product code for Elecsys Phospho-Tau (181P) Plasma is SET.
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Related Devices (Code: SET)
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.