FDA applicant

First Light Diagnostics, Inc.

Chelmsford, MA2 decisions2021–20230 recalls

FDA records 2 decisions for First Light Diagnostics, Inc. (Chelmsford, MA) from 2021 to 2023: 2 510(k) clearances. Most are in product codes LLH (Reagents, Clostridium Difficile Toxin) and QUU (Simple In Vitro Diagnostic Device For The…). 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 First Light Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — First Light Diagnostics, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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First Light Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?