FDA 510(k) Applications for Medical Device Product Code "QYT"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243518 | Abbott Diagnostics Scarborough, Inc. | BinaxNOWÖ COVID-19 Antigen Self Test; BinaxNOWÖ COVID-19 Ag Card | 02/11/2025 |
| K241915 | Access Bio, Inc. | CareSuperbÖ COVID-19 Antigen Home Test | 01/29/2025 |
| K230828 | ACON Laboratories, Inc. | Flowflex COVID-19 Antigen Home Test | 11/09/2023 |
| K233373 | Acon Laboratories, Inc. | Flowflex« Plus COVID-19 Home Test | 04/19/2024 |
| K240728 | CorDx, Inc. | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | 06/21/2024 |
| K241317 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | 09/30/2024 |
| K233842 | iHealth Labs, Inc | iHealth COVID-19 Antigen Rapid Test | 05/31/2024 |
| K241313 | Osang LLC | OHC COVID-19 Antigen Self Test | 05/30/2025 |
| K231795 | Quidel Corporation | QuickVue COVID-19 Test | 03/22/2024 |
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