# Affinity Biosensors, LLC

- Location (FDA's records): Santa Barbara, CA
- FDA decisions: 3 (2024–2025): 3 510(k) clearances
- Names in FDA's records: Affinity Biosensors, LLC (2); Affinity Biosensors (1)
- Product codes: SAN (3)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Accelerate Diagnostics, Inc.: 1 (https://510kreport.com/company/accelerate-diagnostics)

## Its most-cited devices
- K211815: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (2024), cited by 2
- K241324: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (2024), cited by 1

## Recent decisions
- K251875: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (Oct 27, 2025)
- K241324: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (Oct 23, 2024)
- K211815: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (Apr 2, 2024)

Source page: https://510kreport.com/company/affinity-biosensors