K241313 is an FDA 510(k) clearance for the OHC COVID-19 Antigen Self Test. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3984. For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older..
| 510(k) Number | K241313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |