Affinity Biosensors, LLC - FDA 510(k) Cleared Devices
2
Total
2
Cleared
0
Denied
Affinity Biosensors, LLC has 2 FDA 510(k) cleared medical devices. Based in Santa Barbara, US.
Latest FDA clearance: Oct 2025. Active since 2024. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Affinity Biosensors, LLC Filter by specialty or product code using the sidebar.
2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
2 devices