FDA applicant

Alb Luz

Valinhos, BR2 decisions2024–20240 recalls

FDA records 2 decisions for Alb Luz (Valinhos, BR) in 2024: 2 510(k) clearances. Most are in product codes QBD (Microbial Nucleic Acid Storage And…) and JSM (Culture Media, Non-Propagating Transport). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Alb Luz’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

Planning a device like Alb Luz’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

Alb Luz

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?