PrecivityAD2 Test— 510(k) K253240

Substantially Equivalent

C2N Diagnostics, LLC

FDA 510(k) clearance K253240 for PrecivityAD2 Test, Substantially Equivalent on 2026-08-19. Applicant: C2N Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: C2N Diagnostics, LLC
Product code: Code SET
Device class: Class 2
Regulation: 21 CFR 866.5840
Advisory panel: Immunology
Date received: 2025-09-29
Decision date: 2026-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.