Affinity Biosensors, LLC

Affinity Biosensors, LLC holds 2 FDA 510(k) medical device clearances, first cleared 2024, most recent 2025.

Top product codes for Affinity Biosensors, LLC

SAN — Microbiology2 devices

Recent clearances by Affinity Biosensors, LLC

K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemCode SAN·2025-10-27
K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemCode SAN·2024-10-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.