FDA applicant

Armkel, LLC

Cranbury, NJ68 decisions1979–20040 recalls

FDA records 68 decisions for Armkel, LLC (Cranbury, NJ) from 1979 to 2004: 68 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and HIS (Condom). Its devices cite 7 predicates, 5 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Armkel, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Armkel, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?