Access Bio, Inc.
FDA 510(k) & PMA Approved Devices — 3 products
Total Devices3
Categories3
Latest FDA decision2025-08-22
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | SCA | 2025-08-22 | View |
| 510(k) | K241915 | CareSuperb™ COVID-19 Antigen Home Test | QYT | 2025-01-29 | View |
| 510(k) | K191514 | CareStart Flu A&B Plus | PSZ | 2020-02-18 | View |
No matching devices.