Access Bio, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Access Bio, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test, CareSuperb™ COVID-19 Antigen Home Test, CareStart Flu A&B Plus
3
Total
3
Cleared
0
Denied
Access Bio, Inc. has 3 FDA 510(k) cleared medical devices. Based in Somerset, US.
Latest FDA clearance: Aug 2025. Active since 2020. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Access Bio, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Access Bio, Inc.
3 devices