CorDx Tyfast COVID-19 Ag Rapid Test Rx— 510(k) K253882

Substantially Equivalent

CorDx, Inc.

FDA 510(k) clearance K253882 for CorDx Tyfast COVID-19 Ag Rapid Test Rx, Substantially Equivalent on 2026-06-01. Applicant: CorDx, Inc..

Clearance details

Applicant: CorDx, Inc.
Product code: Code QVF
Advisory panel: Microbiology
Date received: 2025-12-04
Decision date: 2026-06-01
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Alpharetta, GA, US

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