Cleared Traditional

OHC COVID-19 Antigen Self Test

K241313 · Osang, LLC · Microbiology

May 2025

Decision

386d

Days

Class 2

Risk

About This 510(k) Submission

K241313 is an FDA 510(k) clearance for the OHC COVID-19 Antigen Self Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Osang, LLC (Pasadena, US). The FDA issued a Cleared decision on May 30, 2025, 386 days after receiving the submission on May 9, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K241313 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2024
Decision Date	May 30, 2025
Days to Decision	386 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.