FDA 510(k)

PrecivityAD2 Test

K-Number: K253240 · 2026-08-19

Decision Date2026-08-19

Product CodeSET

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

PrecivityAD2 Test is the device name listed in this FDA 510(k) record. The listed applicant is C2N Diagnostics, LLC. It received FDA 510(k) clearance on 2026-08-19 under 510(k) number K253240. 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 PrecivityAD2 Test?

PrecivityAD2 Test is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is C2N Diagnostics, LLC. The 510(k) number is K253240.

When did PrecivityAD2 Test receive FDA 510(k) clearance?

PrecivityAD2 Test received FDA 510(k) clearance on 2026-08-19, under 510(k) number K253240.

Who is the listed applicant for PrecivityAD2 Test?

The FDA 510(k) record lists C2N Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PrecivityAD2 Test?

The FDA product code for PrecivityAD2 Test is SET.

Related Devices (Code: SET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc.

Official Source

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