FDA applicant

Affinity Biosensors, LLC

Santa Barbara, CA3 decisions2024–20250 recalls

FDA records 3 decisions for Affinity Biosensors, LLC (Santa Barbara, CA) from 2024 to 2025: 3 510(k) clearances. All are in product code SAN (Automated Antimicrobial Susceptibility Test…). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Affinity Biosensors”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Affinity Biosensors, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024high 2 (2024) · low 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Affinity Biosensors, LLC by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Affinity Biosensors, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Affinity”

FDA records each applicant name separately; these may or may not be the same firm.

Affinity Biologicals, Inc. 5 Affinity Medical Technologies, LLC 1

Affinity Biosensors, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Affinity”