FDA 510(k) Applications for Medical Device Product Code "SCA"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K250377 | ACON Laboratories, Inc. | Flowflex Plus COVID-19 + Flu A/B Home Test | 05/10/2025 |
| DEN240029 | Healgen | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | 10/07/2024 |
| K243561 | Nano-Ditech Corporation | Nano-Check Influenza+COVID-19 Dual Test | 06/17/2025 |
| K243262 | Osang LLC | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | 01/13/2025 |
| K243256 | Wondfo USA Co., Ltd. | WELLlifeÖ COVID-19 / Influenza A&B Home Test; WELLlifeÖ COVID-19 / Influenza A&B AntigenTest | 01/16/2025 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
