QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test— 510(k) K243262

Name: FDA 510(k) clearance K243262
Creator: U.S. Food and Drug Administration
Published: 2025-01-13

Substantially Equivalent

Osang, LLC

FDA 510(k) clearance K243262 for QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test, Substantially Equivalent on 2025-01-13. Applicant: Osang, LLC. Device class: 2.

Clearance details

Applicant: Osang, LLC
Product code: Code SCA
Device class: Class 2
Regulation: 21 CFR 866.3987
Advisory panel: Microbiology
Date received: 2024-10-15
Decision date: 2025-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, 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.