FDA applicant

Cylex, Inc.

Baldwin, MD2 decisions2002–20100 recalls

FDA records 2 decisions for Cylex, Inc. (Baldwin, MD) from 2002 to 2010: 2 510(k) clearances. All are in product code NID (Assay, Proliferation, In Vitro, T Lymphocyte). Its devices cite 4 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, hematology panel, where it files most

How often FDA has decided Cylex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cylex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Cylex, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?