Source document or public record
FDA 510(k) K253240 — PrecivityAD2 Test
FDA 510(k) index record K253240. Device: PrecivityAD2 Test. Applicant as listed: C2N Diagnostics, LLC. Decision date: 2026-08-19.
Source
"device_name": "PrecivityAD2 Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K253240.
Device name: PrecivityAD2 Test. Applicant as listed: C2N Diagnostics, LLC.
Decision date: 2026-08-19. Decision wording: Substantially Equivalent.
Product code: SET. Regulation: 21 CFR 866.5840. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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