CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test— 510(k) K240728

Name: FDA 510(k) clearance K240728
Creator: U.S. Food and Drug Administration
Published: 2024-06-21

Substantially Equivalent

CorDx, Inc.

FDA 510(k) clearance K240728 for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test, Substantially Equivalent on 2024-06-21. Applicant: CorDx, Inc.. Device class: 2.

Clearance details

Applicant: CorDx, Inc.
Product code: Code QYT
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2024-03-18
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.